Doctors at Wake Forest University Baptist Medical Center and 25 other centers will test whether antibiotics can reduce the risk of heart attacks and strokes.
"The study is to determine whether heart disease is an infectious disease that can be treated with an antibiotic." said John R. Crouse III, M.D., professor of internal medicine (endocrinology) and public health sciences, who will head the Wake Forest component of the national clinical trial. "We think it is a really exciting study."
Medical researchers have found that a common type of bacteria, called Chlamydia pneumoniae, may be associated with atherosclerosis — hardening of the arteries. Nearly everybody gets a respiratory infection caused by Chlamydia pneumoniae at some time in their lives, and severe infections can lead to bronchitis and pneumonia.
In the late 1980s, Chlamydia pneumoniae was discovered in samples of diseased coronary artery tissue. Two small trials showed positive results when patients with heart disease were treated with an antibiotic.
The national clinical trial was the outgrowth of those pilot studies. In the trial, to be called the Azithromycin and Coronary Event Study (ACES), doctors will test whether the antibiotic azithromycin (Zithromax) will reduce the risk of heart attacks and strokes.
About 4,000 volunteers will be recruited nationally. Participants will be assigned at random to either a control group that will receive a placebo or the treatment group that will receive azithromycin. For one year, each participant will take one pill each week. Otherwise, participants will not be asked to change their current treatment for heart disease.
They will be followed for three more years to monitor for any coronary events, including hospitalization for heart attack, chest pain, coronary artery bypass grafts, balloon angioplasty (or other similar treatments), or if they die because of complications of coronary artery disease.
"We already have randomized our first 25 patients," Crouse said. "We hope to recruit 150-180 patients for the study."
J. Thomas Grayston, a pioneer in chlamydia research at the University of Washington in Seattle, is the national study director.
"The idea of giving antibiotics to treat a chronic disease like coronary artery disease is not as far-fetched an idea as it once was," said Grayston. "This clinical trial should help prove whether the Chlamydia pneumoniae bacteria plays a direct role in the development or advancement of atherosclerosis.
For more than 40 years, researchers at Wake Forest have pioneered in the study of atherosclerosis, finding that first the pigeon and then the monkey were ideal animal models that would develop the disease when fed a typical American diet. Wake Forest research helped pin down the role of various dietary fats and cholesterol in the development of atherosclerosis.
Despite the research, scientists have only been able to explain about half the heart disease with such risk factors as high blood pressure, smoking, high cholesterol, lack of exercise, obesity and diabetes. For the past decade, they have been searching for other answers.
Coronary artery atherosclerosis that is accelerated by infections such as Chlamydia pneumoniae could be part of that answer.
The 26 centers also include the University of North Carolina at Chapel Hill. The study is being paid for by an $11 million grant from the National Heart, Lung and Blood Institute. Pfizer Corp., the sole producer of azithromycin (Zithromax), is providing the study drug.
To be eligible for the study, a person must already have documented heart disease — from a prior heart attack, from at least a 50 percent blockage of one or more coronary arteries that shows up in heart catheterization, from a prior coronary artery bypass graft, or from a procedure such as balloon angioplasty to clear a clogged artery. For more information, call Greg Terry (336)716-2679 or Telle King (336)716-2848.
Media Contact: Robert Conn, Jim Steele or Mark Wright at (336) 716-4587