Researchers Seek Patients to Participate in "Vulnerable" Plaque Study
Probe Causes of Condition that Killed TV Newsman Tim Russert
Three Boston health care research institutions are seeking heart patients to participate in a study of “vulnerable” soft plaque in coronary arteries that can cause sudden death. The 5-year study is funded by the National Institutes of Health.
This dangerous condition was responsible for the death of 58-year-old TV newsman Tim Russert last spring after the rupture of noncalcified or “vulnerable” plaque -- a buildup of soft deposits embedded deep within the walls of his heart’s arteries. Unlike calcified plaque, which visibly blocks arteries and can therefore be detected and treated through coronary angiography techniques, noncalcified plaque remains well hidden, undetectable by cardiac stress tests. Without warning, it can suddenly detach from the artery wall, as happened in Russert’s case – resulting in sudden death.
A team of Boston researchers seeks more than 700 men and women, ages 21-70, to participate in a study of the causes of vulnerable plaque. Participants must have a diagnosis of coronary artery disease as well as metabolic syndrome, a precursor of diabetes characterized by obesity, high blood pressure, low "good" cholesterol and a high level of triglyceride fat in the blood.
Because recent studies have demonstrated that low-grade inflammation is involved in the formation of plaque, this new clinical trial has been designed to evaluate whether reducing inflammation can reduce the progression of plaque in patients with existing heart disease, according to study investigators Francine Welty, MD, of BIDMC and Allison Goldfine, MD, of Joslin Diabetes Center.
As part of the study, a highly precise method of detecting and measuring noncalcified plaque will be used to assess the outcomes. Known as voxel analysis in conjunction with multidector cardiac tomography (MDCT), the new method – developed at BIDMC -- can provide doctors with a comprehensive series of more than 2,300 measurements that paint a vivid picture of the coronary arteries and surrounding area, including the amount and location of vulnerable plaque in the otherwise hidden confines of the artery walls.
Study participants will undergo two free scans using a highly precise 320-slice MDCT scanner to assess the incidence – and amount – of plaque and the effects of treatment. They will also receive compensation for their time and the satisfaction of helping to advance knowledge of heart disease. Patients randomly selected to participate in one section of the study will receive free coaching on diet, exercise and other aspects of a healthy lifestyle.
Known by its acronym, TINSAL-CVD, the trial has begun enrolling patients at Beth Israel Deaconess Medical Center, Joslin Diabetes Center, Tufts Medical Center, and other New England hospitals to learn whether lifestyle interventions (diet, exercise and use of an Omega-3 fatty acid supplement) or the use of a salsalate (a non-steroidal anti-inflammatory drug) can reduce the incidence of inflammation, believed to be a key factor in the development of vulnerable plaque – and the risk of sudden death.
Heart patients who are interested in participating in the study may call Dr. Michelle McKenney at 617-632-7656 or email mckenne@bidmc.harvard.edu.
Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.
Posted January 2009
