Author Archives: medicalresearch

Report: New More-Sensitive Blood Test Catches Recurring Breast Cancer a Year Earlier

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Newswise — SAN DIEGO, March 28, 2012 Research was presented at a meeting of the American Chemical Society — A new blood test is twice as sensitive and can detect breast cancer recurrence a full year earlier than current blood tests, according to a scientist who reported here today at the 243rd National Meeting & Exposition of the American Chemical Society (ACS). The report was among more than 11,000 presentations on new developments in science scheduled this week at the meeting, held by the world’s largest scientific society.

Daniel Raftery, Ph.D., who reported on the test, pointed out that breast cancer survivors — 2.5 million in the U.S. alone — face about a 1-in-5 chance that the cancer will come back, or recur, within 10 years of treatment. Research shows that early detection of these recurrences and treatment can save lives. However, currently available blood tests are not very sensitive. Perhaps the best known test for a biological “marker” protein, or “biomarker,” called CA 27.29, misses many cases of recurrence and detects them late — often after symptoms, such as difficulty breathing or bone pain, surface.

“We have identified a group of nine biomarkers that signal recurrence of breast cancer,” Raftery said. “Our markers detect twice as many recurrences as the CA marker does at the same specificity. They also detect cancer recurrence earlier, about 11-12 months sooner than existing tests. They accomplish this with blood samples, rather than biopsies, with less discomfort to patients.”

To find these markers, Raftery’s team at Purdue University and Matrix-Bio, Inc., a company he founded, analyzed many hundreds of “metabolites” in the blood of breast cancer survivors. Metabolites are small molecules, biological byproducts formed as the body’s cells go about the business of life. Some are released into the bloodstream and urine. The rapidly emerging scientific field called “metabolite profiling” seeks to understand how these metabolites relate to health and disease. Groups of metabolites already have been linked to a range of diseases. Many of Raftery’s biomarkers were known to be involved in cancer. But no one knew that this group of metabolites could serve as biomarkers for breast cancer recurrence, he said.

The markers are detected with an instrument called a mass spectrometer, which is common in clinical laboratories. Raftery explained that these markers would be used in combination with results from CA 27.29 blood tests.

“We take both of those results together and roll them into the profile so that the score we generate is a combination of the CA value and our nine metabolites,” he said. “If the score indicates that the cancer probably has returned, the patient would then likely undergo imaging tests to locate the tumor.”

Raftery hopes that the new test will become available later this year. In the meantime, the researchers are conducting another clinical study with the test. He also said that, in the future, the test might be useful in the early detection of breast cancer, not just recurrences.

The scientists acknowledged partial funding from the National Institutes of Health.

Report: US Cancer Death Rates Continue to Fall

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Newswise — BOSTON—A report from the nation’s leading cancer organizations shows rates of death in the United States from all cancers for men and women continued to decline between 2004 and 2008. The findings come from the latest Annual Report to the Nation on the Status of Cancer.

The report also finds that the overall rate of new cancer diagnoses for men and women combined decreased an average of less than one percent per year from 1998 through 2006, with rates leveling off from 2006 through 2008. Edward J. Benz, Jr., MD, president of Dana-Farber Cancer Institute in Boston, called the news encouraging, but is disappointed that the overall rate of cancer deaths is not falling nearly enough.

“The rate of cancer diagnoses and deaths across all racial and minority groups are slowly decreasing,” said Benz. “But there are still gaps that must be addressed.”

The report is co-authored by researchers from the Centers for Disease Control and Prevention, the North American Association of Central Cancer Registries, the National Cancer Institute, and the American Cancer Society. It will be posted on the web site of the journal CANCER on March 28, 2012.

Among children ages 19 years or younger, the report shows cancer incidence rates increased 0.6 percent per year from 2004 through 2008, while death rates decreased 1.3 percent per year during the same period.

The authors also highlighted cancers associated with excess weight and lack of sufficient physical activity.

“This report emphasizes that the growing obesity problem and decreased overall physical activity in our society compared to decades ago have a real impact on multiple diseases, including cancer,” said Jeffrey A. Meyerhardt, MD, MPH, a colorectal cancer expert at Dana-Farber and author of several studies investigating the impact of exercise on survival rates for colorectal cancer patients. “While we currently see declines in incidence of many cancers, if obesity continues at the current rates, I believe these improvements in incidences will reverse and increase over time.”

Benz added that the good news is that some of the cancer risks the report highlighted can be reduced by changes in lifestyle.

“Many of the things that are still a problem in these statistics are modifiable,” said Benz. “If you watch your diet, exercise, and manage your weight, you can not only prevent your risk of getting many lethal forms of cancer, you will also increase your chances of doing well, if you should get almost any form of cancer.”

Dietary Cadmium May Be Linked with Breast Cancer Risk

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Newswise — PHILADELPHIA — Dietary cadmium, a toxic metal widely dispersed in the environment and found in many farm fertilizers, may lead to an increased risk of breast cancer, according to a study published in Cancer Research, a journal of the American Association for Cancer Research.

Cadmium occurs at low concentrations naturally, but scientists are concerned because contamination of farmland mainly due to atmospheric deposition and use of fertilizers leads to higher uptake in plants.

“Because of a high accumulation in agricultural crops, the main sources of dietary cadmium are bread and other cereals, potatoes, root crops and vegetables,” said Agneta Åkesson, Ph.D., associate professor at Karolinska Institutet in Sweden. “In general, these foods are also considered healthy.”

For the current study, Åkesson and colleagues observed 55,987 women for more than 12 years. They estimated the dietary cadmium exposure using a food frequency questionnaire. During the follow-up period, researchers observed 2,112 incidences of breast cancer including 1,626 estrogen receptor-positive and 290 estrogen receptor-negative cases.

Cadmium consumption was divided into three groups with the highest levels of exposure compared with the lowest. Overall, a higher exposure to cadmium via diet was linked with a 21 percent increase in breast cancer. Among lean and normal weight women, the increased risk was 27 percent.

Both estrogen receptor-positive and negative tumors had the same risk increase at roughly 23 percent. Åkesson said that women who consumed higher amounts of whole grain and vegetables had a lower risk of breast cancer compared to women exposed to dietary cadmium through other foods.

“It’s possible that this healthy diet to some extent can counteract the negative effect of cadmium, but our findings need to be confirmed with further studies,” said Åkesson. “It is, however, important that the exposure to cadmium from all food is low.”

Study Suggests Link Between H. pylori Bacteria and Blood Sugar Control in Adult Type II Diabetes

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Newswise — NEW YORK, March 14, 2012 – A new study by researchers at NYU Langone Medical Center reveals that the presence of Helicobacter pylori (H. pylori) bacteria is associated with elevated levels of glycosylated hemoglobin (HbA1c), an important biomarker for blood glucose levels and diabetes. The association was even stronger in obese individuals with a higher Body Mass Index (BMI). The results, which suggest the bacteria may play a role in the development of diabetes in adults, are available online in The Journal of Infectious Diseases.

There have been several studies evaluating the effect of the presence of H. pylori on diabetes outcomes, but this is the first to examine the effect on HbA1c, an important, objective biomarker for long-term blood sugar levels, explained Yu Chen, PhD, MPH, associate professor of epidemiology at NYU School of Medicine, part of NYU Langone Medical Center.

“The prevalence of obesity and diabetes is growing at a rapid rate, so the more we know about what factors impact these conditions, the better chance we have for doing something about it,” Dr. Chen said. Looking at the effects of H. pylori on HbA1c, and whether the association differs according to BMI status, provided what could be a key piece of information for future treatment of diabetes, she explained.

Type II diabetes causes an estimated 3.8 million adult deaths globally. There have been conflicting reports about the association between H. pylori infection and type II diabetes. To better understand the relationship between H. pylori and the disease, Dr. Chen and Martin J. Blaser, MD, the Frederick H. King Professor of Internal Medicine and professor of microbiology, analyzed data from participants in two National Health and Nutrition Surveys (NHANES III and NHANES 1999-2000) to assess the association between H. pylori and levels of HbA1c.

“Obesity is an established risk factor for diabetes and it is known that high BMI is associated with elevated HbA1c. Separately, the presence of H. pylori is also associated with elevated HbA1c,” said Dr. Blaser, who has studied the bacteria for more than 20 years. “We hypothesized that having both high BMI and the presence of H. pylori would have a synergistic effect, increasing HbA1c even more than the sum of the individual effect of either risk factor alone. We now know that this is true.”

H. pylori lives in the mucous layer lining the stomach where it persists for decades. It is acquired usually before the age of 10, and is transmitted mainly in families. Dr. Blaser’s previous studies have confirmed the bacterium’s link to stomach cancer and elucidated genes associated with its virulence, particularly a gene called cagA.

Regarding H. pylori’s association with elevated HbA1c, Drs. Chen and Blaser believe the bacterium may affect the levels of two stomach hormones that help regulate blood glucose, and they suggest that eradicating H. pylori using antibiotics in some older obese individuals could be beneficial.

More research will be needed to evaluate the health effects of H. pylori and its eradication among different age groups and in relation to obesity status, the authors noted.

“If future studies confirm our finding, it may be beneficial for individuals at risk for diabetes to be tested for the presence of H. pylori and, depending on the individual’s risk factor profile” Dr. Chen.

In an accompanying editorial in The Journal of Infectious Diseases, Dani Cohen, PhD, of Tel Aviv University in Israel, pointed out that while previous studies have addressed the association between type II diabetes and H. pylori in small samples, this study analyzed two independent large national samples of the general population. Dr. Cohen agreed with the study authors, suggesting that adults infected with H. pyloriwith higher BMI levels, even if asymptomatic, may need anti-H. pylori therapy to control or prevent type II diabetes. If the study findings are confirmed, Dr. Cohen wrote, they “could have important clinical and public health implications.”

U.S. Tobacco-Control Efforts Prevented Nearly 800,000 Lung Cancer Deaths Between 1975 and 2000

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Newswise — SEATTLE – Declines in cigarette smoking among Americans since the mid-1950s – particularly since tobacco-control policies and interventions were implemented after the U.S. Surgeon General’s Report on Smoking and Health was released in 1964 – prevented nearly 800,000 lung cancer deaths between 1975 and 2000, according to a study led by researchers at Fred Hutchinson Cancer Research Center.

Results of the National Cancer Institute-funded study, conducted by a consortium of six research groups in the U.S. and the Netherlands, are published online in the Journal of the National Cancer Institute.

For the study, the researchers, part of the NCI’s Cancer Intervention and Surveillance Modeling Network, reconstructed detailed smoking histories for those born between 1890 and 1970, and then estimated lung cancer deaths associated with these smoking histories using mathematical equations. In this way, the researchers were able to estimate the impact of changes in smoking patterns resulting from tobacco-control efforts on deaths from lung cancer between 1975 and 2000.

“This is the first attempt to quantify the impact of changes in smoking behaviors on lung cancer mortality based on detailed reconstruction of cigarette smoking histories,” said lead author Suresh H. Moolgavkar, M.D., Ph.D., an epidemiologist, biostatistician and mathematical modeler in the Hutchinson Center’s Public Health Sciences Division. He is an expert in devising formulas, equations and computer programs that simulate and predict biological processes. Such studies contribute to the understanding of cancer risks associated with exposures to toxic chemicals such as cigarette smoke.

Since the mid-‘60s, tobacco-control efforts in the U.S. have included restrictions on smoking in public places, increases in cigarette excise taxes, limits on underage access to cigarettes, and efforts to increase public awareness of the hazards of smoking.

In addition to modeling the impact of actual tobacco control efforts on lung cancer mortality rates, the researchers also estimated lung cancer deaths between 1975 and 2000 under two opposite scenarios:

• If all U.S. cigarette smokers had successfully quit smoking in the wake of the 1964 Surgeon General’s report and no one else started smoking, an estimated 2.5 million people would have not died from lung cancer (1.6 million men and 883,000 women would not have been diagnosed with the disease).
• In the absence of tobacco control programs and policies, if smoking behaviors had not changed after the Surgeon General’s report, an additional 552,000 men and 243,000 women would have died of lung cancer.

“These findings provide a compelling illustration of the devastating impact of tobacco use in our nation and the enormous benefits of reducing rates of smoking,” said Robert Croyle, Ph.D., director of the NCI’s Division of Cancer Control and Population Sciences. “Although great strides have been made, we cannot relax our efforts. The prevention and cessation of tobacco use continue to be vital priorities for the medical, scientific and public health communities.”

Researchers reveal ways to make personalized cancer therapies more cost effective

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AURORA, Colo. — As scientists continue making breakthroughs in personalized cancer treatment, delivering those therapies in the most cost effective manner has become increasingly important. Now researchers at the University of Colorado School of Medicine have identified new ways of doing just that, allowing more patients to benefit from this revolution in cancer care.

In a paper published in the British Journal of Cancer, health economist Adam Atherly, PhD, of the Colorado School of Public Health (CSPH) and medical oncologist D. Ross Camidge, MD, PhD, of the University of Colorado Cancer Center, argue the cost of profiling patients’ tumors for specific molecular abnormalities must be considered. This kind of molecular profiling is increasingly being used to determine who would benefit most from a variety of cancer drugs. In addition, many new drugs are now being restricted to cancer patients with specific molecular sub-types of the disease. Many of these initial breakthroughs have happened in lung cancer, but dividing one disease into many different sub-diseases at the molecular level is expected to extend across most of cancer medicine in the next few years.

“In recent years, we have championed the practice of performing very sophisticated molecular tests on the tumors of every lung cancer patient we see. We then use this information to direct patients to the most appropriate targeted therapy for their cancer,” said Camidge, CU Cancer Center investigator and director of the thoracic oncology clinical program at University of Colorado Hospital (UCH).

Camidge continues, “The testing has certainly led to major breakthroughs in the treatment of lung cancer. But if we are going to roll these developments out across the U.S. and around the world, we have to understand what this progress costs and how to make it affordable.”

Many insurers already consider the cost of a drug and the benefit derived from its use when determining coverage. In their paper, Atherly and Camidge reveal that the cost of testing tumors for an increasing array of specific genetic abnormalities must now also be considered.

“If you screen every patient with a molecular test to detect something that only occurs in one percent of them – in reality, treating each positive patient should also include the upfront costs of screening the other 99 negative patients,” said Atherly, professor of health systems management and policy for the Colorado School of Public Health. “If a test costs $1,000, this means from society’s perspective you have to add $100,000 to the costs of treating each of the one in 100 patients that are positive. And this is before you have even started to consider the cost of the drug itself. When you consider these factors, some organizations may not view a new drug as cost effective even if it works amazingly well for the small percentage who are proven positive by the test.”

Using recent breakthroughs by the University of Colorado’s lung cancer program to model their data, Atherly and Camidge argue pricing of the molecular profiling tests and policies on who and how to screen for abnormalities should be carefully considered or treatment of many different cancers may be delayed. They suggest two key ways molecular profiling can be made more cost effective. First, clinicians could recommend testing only some patients based on finding certain key clinical factors that increase the chances of a patient having a specific molecular abnormality in their tumor. The downside is that some positive patients may be missed if they don’t fit a classical stereotype. Second, either the cost of the profiling test for each individual molecular abnormality has to be reduced for every patient screened, or tests must be merged so doctors can look for multiple different abnormalities at the same time at a lower combined price.

“We believe the only way to beat cancer is moving away from the one-size-fits-all model,” said Camidge. “To do this we must treat every person as an individual. But if we don’t think now about the costs of this approach and how to address them, these breakthroughs will never achieve their true potential.”

Study: Cancer of the Appendix is Different than Colon Cancer

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WINSTON-SALEM, N.C. – March 7, 2012 – Researchers at Wake Forest Baptist Medical Center have demonstrated that cancer of the appendix is different than colon cancer, a distinction that could lead to more effective treatments for both diseases.

The study by Edward A. Levine, M.D., professor of surgery and chief of the surgical oncology service at Wake Forest Baptist, is the result of gene analysis of cases covering a 10-year period. It appears in the early online edition of the April issue of the Journal of the American College of Surgeons.

Cancer of the appendix, which is part of the colon, affects approximately 2,500 people in the United States annually and has the propensity to spread throughout the peritoneal cavity, the space within the abdomen that contains the intestines, stomach and liver.

“Our treatment program, which was the catalyst for this research, is one of the largest worldwide and consists of aggressive surgery coupled with heated chemotherapy placed directly into the abdominal cavity at the time of surgery,” Levine said. “Given the uncertainty of predicting outcomes in patients with disseminated appendiceal cancer, we sought to use the tools of gene expression profiling to better understand these rare malignancies at a molecular level in order to better predict oncologic outcomes. We’ve looked at the genes that make these cancers tick, and we actually started to pick them apart for the first time.”

For the study, the researchers examined tumor samples from Wake Forest Baptist’s tissue bank for patterns of expression of different genes.

“By looking at these genetic signatures, we found that the genes active in cancer of the colon and those active in cancer of the appendix are very different,” Levine said. “For years, however, cancer of the appendix, which is part of the colon, has been treated with the same chemotherapy treatment used for colon cancer. This study shows that we need a fresh approach to how we treat appendix cancer.”

This research, which was done in collaboration with Duke University, was supported, in part, by a grant from Golfers Against Cancer. Co-authors include Perry Shen, M.D., and John Stewart, M.D., both of Wake Forest Baptist, and David Hsu, M.D., and Trey Blazer, M.D., both of Duke University.

HIV Rates for Black Women in Parts of the US Much Higher than Previously Estimated

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Newswise — 3/09/2012 – Newark is one of six locations in the United States that are the focus of a new study whose findings indicate that the HIV incidence rate for US women living in areas hardest hit by the epidemic is much higher than the overall estimated incidence rate in the US for black women. The study was designed, and the national research team chaired, by Sally Hodder, MD, professor and vice chair of the Department of Medicine at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School.

At the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, the HIV Prevention Trials Network (HPTN) announced results from its HPTN 064 Women’s HIV Seroincidence Study (ISIS) which found an HIV incidence of 0.24% in the study cohort of 2,099 women (88% black), a rate that is fivefold higher than that estimated for black women overall by the Centers for Disease Control and Prevention (CDC). The rate noted in the HPTN 064 (ISIS) study is comparable to estimated HIV incidence rates in the general population in several countries in sub-Saharan Africa including the Congo (0.28 %) and Kenya (0.53%), underscoring the substantial ongoing HIV transmission within specific US populations, including women at risk as defined in this study. The six geographical areas in the US chosen for the study are locations where HIV and poverty are known to be more common.

Hodder, who also is director of the HIV/AIDS Program in the Division of Infectious Diseases of New Jersey Medical School, said about the findings, “We have known that black women in the US are disproportionately impacted by HIV, however, the magnitude of this disparity in areas hardest hit by the HIV epidemic underscores the gravity of the problem.”

Women constitute roughly one-quarter of new HIV infections in the US with 66 percent of these infections occurring among black women, although black women constitute only 14 percent of the US female population. In the US, the age-adjusted death rate of black women with HIV is roughly 15 times higher than that observed for HIV-infected white women. “Despite prevention efforts in the last 30 years, the reality is that we still have ongoing HIV transmission in the US that requires focusing prevention efforts,” said Hodder.

While at CROI, Hodder also described additional research that is focused specifically on Newark. Using data on the HIV-positive population in Newark collected from 2002-09, Hodder and a team of researchers created a model to predict which interventions might be most effective in controlling the epidemic. The four interventions tested were 1) increased HIV testing coverage, 2) decreased time from infection to testing, 3) decreased dropout of patients from treatment programs, and 4) improved use of therapies to suppress viral load in people who are infected. The model suggests that the best approach by far would be a combination of all four of those interventions, leading to a projected reduction the incidence of infection by 39% and in the number of deaths by 45.8%. No single approach among the four is projected to achieve results that are even half as positive as combining all of the interventions within the affected population.

HPTN 064 (ISIS) Study Background:
The HPTN 064 (ISIS) study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institute of Health, enrolled a total of 2,099 women, ages 18 to 44 years, between May 2009 and July 2010. Eighty-eight percent of women were black, 12% Hispanic/Latina. Women were enrolled from 10 communities in six distinct geographical areas in the northeast and southeast regions of the US; Atlanta, GA, Raleigh-Durham, NC, Washington D.C., Baltimore, MD, Newark, NJ, New York City, NY.

The study used a novel approach to recruit participants, focusing on geographic areas of the US with the highest HIV prevalence rates in women, i.e. ‘hot spots’. Women without a prior positive HIV test living in areas with high HIV prevalence and poverty were eligible for enrollment and were interviewed about many key aspects of their lives including mental health, sexual behavior, history of sexually transmitted infections (STIs), domestic violence, social support, financial insecurity and health care utilization.

Another significant finding from the study is the high number of women who were found to have HIV infection at the time of enrollment (32 women or 1.5%). These women were previously unaware of their HIV status. This finding highlights the need to increase awareness of HIV risk and expand novel HIV testing and prevention efforts in high prevalence areas of the US.

“The study provides convincing evidence that more effort is needed to develop effective prevention strategies for high risk populations in order to stem the HIV epidemic in the US,” said Sten Vermund from Vanderbilt University, Principal Investigator of the HPTN.

Bacterial STD Linked to Increased Risk of HIV

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Newswise — 3/9/2012  — A common sexually transmitted bacterial infection more than doubles the risk of HIV infection in African women, according to a study by researchers at RTI International.

The study, published in the March 13 issue of AIDS, found that women with the “emerging” sexually transmitted disease Mycoplasma genitalium are more likely to acquire HIV infection.

“Further research will be required to confirm a causal relationship and to identify risk factors for M. genitaliuminfection in African populations,” said Sue Napierala Mavedzenge, Ph.D., a research investigator with theWomen’s Global Health Imperative at RTI International and the study’s lead author. “If findings from this research are confirmed, M. genitalium screening and treatment among women at high risk for HIV-1 infection may be warranted as part of an HIV-1 prevention strategy.”

First discovered in 1980, M. genitalium is a bacterial STD that causes inflammatory conditions of the genitals and reproductive tract (urethritis, cervicitis and pelvic inflammatory disease). The infection, which may be present for years without causing any symptoms, can be eliminated with appropriate antibiotics.

This study used data from a larger study of HIV acquisition among young women in Zimbabwe and Uganda to assess the effects of M. genitalium on HIV risk. In the study, 190 women who became infected with HIV during follow-up were matched to women of similar age and risk who did not acquire HIV. Both groups were tested for the presence of M. genitalium, which was evaluated as a risk factor for HIV infection.

In initial samples, when all women were HIV free, infection with M. genitalium was present in about 15 percent of women who later developed HIV versus 6.5 percent in women who remained HIV free. Mycoplasma genitalium was more frequent than other bacterial STDs, including gonorrhea and chlamydia.

The researchers found that after adjustment for other factors, women who initially had M. genitalium were more than twice as likely to become infected with HIV. Certain other STDs were also risk factors for HIV.

The researchers estimated that about 9 percent of all HIV infections occurring in the study were attributable to M. genitalium. However, other factors were more strongly associated with HIV risk, especially the presence of herpes simplex virus 2 (the virus that causes genital herpes) and having a partner with HIV risk factors.

 

NIH launches trials to evaluate CPR and drugs after sudden cardiac arrest

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The National Institutes of Health has launched two multi-site clinical trials to evaluate treatments for out-of-hospital cardiac arrest. One will compare continuous chest compressions (CCC) combined with pause- free rescue breathing to standard cardiopulmonary resuscitation (CPR), which includes a combination of chest compressions and pauses for rescue breathing. The other trial will compare treatment with the drug amiodarone, another drug called lidocaine, or neither medication (a salt-water placebo) in participants with shock-resistant ventricular fibrillation, a condition in which the heart beats chaotically instead of pumping blood.

The majority of the approximately 350,000 people who have cardiac arrest in the United States each year are assessed by emergency medical service (EMS) providers. During a cardiac arrest, the heart stops beating, and unless it is restarted within minutes, the person usually dies. Although immediate CPR can be lifesaving, more than 90 percent of people who experience a cardiac arrest outside of a hospital die before reaching a hospital or soon thereafter.

“Increasing survival rates for people who experience out-of-hospital cardiac arrest is a major public health goal,” said Susan B. Shurin, M.D., acting director of the NIH’s National Heart, Lung, and Blood Institute, which is the lead federal sponsor of the studies. “These new trials could provide critical insight about which resuscitation efforts are most effective for cardiac arrest.”

The trials will serve a combined population of nearly 21 million people from diverse urban, suburban, and rural regions across the U.S. and Canada.

The CCC trial will compare survival-to-hospital-discharge rates for two CPR approaches delivered by paramedics and fire fighters. Persons experiencing cardiac arrest will be randomly assigned to receive continuous chest compressions, or standard CPR by emergency responders. Standard CPR, the approach recommended by the American Heart Association (AHA) for use by emergency responders, includes chest compressions with short pauses for assisted breathing. This approach has been called into question by emerging data suggesting that stopping chest compressions to provide assisted breathing interrupts overall blood flow, thereby lowering survival.

Previous studies have shown that people who suffer cardiac arrest outside of the hospital and are treated by bystanders are more likely to survive when given compressions alone, according to Graham Nichol, M.D., M.P.H., principal investigator of the CCC trial and a professor of medicine and director of the Center for Prehospital Emergency Care and medical director of the Clinical Trials Center at the University of Washington, Seattle. In 2010, AHA adopted new guidelines that recommended continuous chest compressions only for bystanders.

“The CCC trial will help to determine if continuous compressions are equal to or better than standard professional CPR when paramedics, who are better able to provide assisted breathing than bystanders, intervene,” said Nichol.

Trained emergency personnel will give all participants in the CCC trial three cycles of CPR followed by heart rhythm analysis and, if needed, an electrical shock (defibrillation), applied to the chest. Half will be randomly assigned to receive continuous compressions combined with pause-free rescue breathing and half will receive standard professional CPR.

The CCC trial will enroll up to 23,600 participants at eight major regional locations across the U.S. and Canada.

The Amiodarone, Lidocaine, or neither (Placebo) for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia study (ALPS) will determine whether amiodarone or lidocaine improves survival-to-hospital-discharge rates for participants with shock-resistant ventricular fibrillation. Participants will receive one or the other drug or a placebo.

About 25 percent of cardiac arrests are due to ventricular fibrillation. When shock treatment with a defibrillator fails to restore normal heart rhythm during ventricular fibrillation, medications such as amiodarone or lidocaine are often given, but their effectiveness in improving survival is unknown.

“Answering these questions is crucial and will determine the role of these drugs for patients who experience out-of-hospital cardiac arrest,” said Peter Kudenchuk, M.D., principal investigator of the ALPS trial and the Seattle-King County Resuscitation Outcomes Consortium (ROC) clinical site, and professor of medicine and heart rhythm specialist at the University of Washington School of Medicine, Seattle.

The ALPS trial will enroll up to 3,000 participants at nine locations across the U.S. and Canada.

CCC and ALPS are part of the NIH-supported ROC, the first large-scale clinical research network in the world designed to study, improve, and standardize how EMS teams deliver very early, pre-hospital interventions to improve patient survival after cardiac arrest or trauma. ROC has forged innovative multidisciplinary research partnerships between emergency physicians, cardiologists, EMS workers, trauma surgeons, and neurosurgeons to bring diverse perspectives to research that ultimately will lead to better clinical practice. As with all clinical trials funded by the NIH, an independent group of experts will monitor patient safety throughout both trials.

The NHLBI is the lead federal sponsor for both of the new studies, and the U.S. Army Medical Research and Materiel Command is a federal co-sponsor. Additional funding is provided by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Canada, the Defense Research and Development Canada, and the AHA.

Almost 60 fire and EMS organizations will participate in the ALPS trial, and approximately 125 EMS organizations will participate in the CCC trial.

Participating centers include:

  • Alabama Resuscitation Center, University of Alabama at Birmingham
  • University of California, San Diego Center for Resuscitation Science (ALPS only)
  • Portland Resuscitation Outcomes Consortium, Oregon Health and Science University (ALPS only)
  • Pittsburgh Resuscitation Network, University of Pittsburgh (CCC only)
  • Dallas-Fort Worth Center for Resuscitation Research, University of Texas Southwestern Medical Center
  • Seattle-King County Center for Resuscitation Research, University of Washington
  • Milwaukee Resuscitation Network, Medical College of Wisconsin
  • University of Ottawa Collaborative Regional Coordinating Centre, Ottawa Hospital Research Institute, Canada
  • University of British Columbia Collaborative Regional Coordinating Centre, St. Paul’s Hospital, Canada
  • Rescu, Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Canada

Both trials will be coordinated by the University of Washington in Seattle.

Find out more about the CCC trial at http://clinicaltrials.gov/ct2/show/NCT01372748 and about ALPS athttp://clinicaltrials.gov/ct2/show/NCT01401647