This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Coronary heart disease is obviously a major public health problem and the leading cause of death in the United States. Chelation therapy has been proposed to decrease the risk of CAD, but rigorous testing of this hypothesis is lacking and there is inadequate data available. This study proposes to address that gap in knowledge. This is a 5-year randomized, double-blind, placebo-controlled 2X2 factorial trial designed to test the effects of the standard chelation solution recommended by the American College for Advancement in Medicine, as well as the effects of a high-dose antioxidant vitamin and mineral supplementation, versus a low-dose regimen to simply replace chelation-related losses. The Phase III, NIH-sponsored multicenter trial is designed to determine whether chelation or high-dose supplements in patients with coronary heart disease will reduce the incidence of clinical cardiovascular effects and to determine whether treatment has acceptable safety profiles. The primary endpoint will be a composite of all-cause mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for angina. Major secondary endpoints will include cardiovascular death or nonfatal MI or nonfatal stroke. Clearly, if the therapy is efficacious it will have a major impact on patient care. This study was recently initiated on the GCRC.
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