Deborah Joins NIH for Landmark Research
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Deborah Joins NIH for Landmark Research Deborah Heart and Lung Center has joined the National Heart, Lung and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health in the Trial to Assess Chelation Therapy (TACT), the first large-scale clinical trial investigating the safety and effectiveness of Chelation Therapy for coronary artery disease. If this treatment proves successful in reducing atherosclerotic plaque in study participants, it will provide the scientific evidence needed to add Chelation Therapy to the arsenal of proven treatment options for heart disease, such as angioplasty and bypass surgery. Chelation Therapy involves the intravenous administration of ethylene diamine tetra-acetic acid (EDTA), a synthetic amino acid. EDTA removes heavy metals and minerals from the blood, including calcium, iron, zinc, copper, manganese and lead, which may reduce atherosclerotic plaque and vascular events. “Though the safety and effectiveness of Chelation Therapy has not yet been proven in a large-scale clinical trial, it has been used by privately practicing physicians, cardiologists and alternative medicine specialists for many years. In fact, hundreds of thousands of patients receive this therapy annually, typically at a non-reimbursable cost of several thousand dollars per year,” stated Robert Faillace, MD, Attending Cardiologist. “Deborah’s participation in this clinical research will contribute to the body of knowledge of coronary artery disease.” |
Study participants will be randomized to receive EDTA or placebo, and will receive 30 weekly infusions, followed by 10 bimonthly infusions at participating hospitals or heart centers. Participants in both the Therapy and Placebo groups will be further randomized to receive either a high-dose active vitamin regimen or a high-dose placebo vitamin regimen. All participants will receive a low-dose vitamin supplement to replace the minerals that would be lost during Chelation Therapy. “The vitamin supplements will be given during this trial because they are part of the Therapy as it is frequently given by physicians who currently use Chelation Therapy,” explained Dr. Faillace. “By further randomizing both groups to receive vitamins, the NHLBI hopes to also determine whether supplemental vitamins augment the potential effect of Chelation, or whether the vitamins have plaque-reduction effects on their own.”
To qualify for participation in TACT, patients must be at least 50 years old, have documentation of myocardial infarction at least six weeks prior to study participation, and must not have received Chelation Therapy within the past five years. The trial’s primary endpoint will be a composite of all-cause mortality, myocardial infarction, stroke, hospitalization for angina, and hospitalization for congestive heart failure. Major secondary endpoints will include: a combined endpoint of cardiac death, nonfatal myocardial infarction or nonfatal stroke; coronary revascularization; safety of the interventions including indices of renal, hepatic and hematological function; health-related quality of life; cost and cost-effectiveness; and others. The NHLBI expects approximately 2,400 patients to be recruited at about 100 centers nationwide for the five-year trial. |
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