TACT: Trial to Assess Chelation Therapy   Sponsors     National Heart, Lung and Blood Institute (NHLBI) and the National Center for Complementary and Alternative Medicine (NCCAM), U.S. National Institutes of Health   Principal Investigators     Gervasio A. Lamas, MD, Mount Sinai Medical Center Charles H. Hennekens, MD, DrPH, Mount Sinai Medical Center   Berman Center Site Principal Investigator     Richard Grimm, MD, PhD, MPH   Berman Center Site Coordinator     Mary Perron, RN, 612-341-7921   Description     This randomized, double-blinded, placebo-controlled trial will enroll 2372 participants at high risk for heart disease. It is a 2x2 factorial: One factor is chelation therapy vs. placebo, and the other is high-dose antioxidant vitamin/mineral daily supplements vs. placebo. Participants are followed for an average of 2.5 years.   Role of the Berman Center     The Berman Center is one of 150 clinical sites participating in the trial. The Berman Center’s goal is to enroll 15 participants. The Berman Center will recruit and screen participants, randomize them, and perform all study treatments (including the chelation infusions), collect all study measurements, and follow all participants through the end of the trial.   Basic enrollment information     • Age ≥50 years (if female, post-menopausal) • MI > 6 weeks ago with other heart disease symptoms • No prior chelation therapy within 5 years   Abstract     Chelation therapy is a commonly used CAM practice for preventing heart disease. In the community, it involves intravenous administration of EDTA combined with high dose antioxidant vitamin and mineral supplements. It has been estimated that over one million patients have received more than 20 million infusions. However, there have been few randomized trials to test safety, or to test the effectiveness of one or more of the elements of the infusion.     The Trial to Assess Chelation Therapy (TACT) is a 5-year, randomized, double-blind, placebo-controlled 2x2 factorial trial. The two factors are chelation vs. placebo, and high dose vitamin/mineral supplement vs. low dose. All participants receive low-dose vitamins. The primary outcome is the incidence of clinical cardiovascular events during the 5-year trial period. Other outcomes include quality of life, and the relative cost-effectiveness of the therapies.     The trial will enroll 2372 participants, age 50 or older, with a prior myocardial infarction. Following baseline assessments, participants will be randomly assigned to receive 40 infusions of either the chelation or placebo solution, and also be randomized to either the high- or low-dose vitamin/mineral supplements. All participants will be followed for clinical events until the end of the trial.