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. This is a five-year, multicenter, randomized, double-blind, placebo-controlled trial designed to test the efficacy of the standard chelation solution recommended by the American College for Advancement in Medicine (intravenous administration of disodium ethylenediaminetetraacetic acid (EDTA)), 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. EDTA is approved for use by the FDA as a treatment for lead poisoning but not for coronary artery disease, as it is being used in this study.
The specific aims for this trial are: 1) to determine whether chelation or high-dose supplements in patients with coronary heart disease (CHD) will reduce the incidence of clinical cardiovascular events, and 2) to determine whether chelation and high-dose supplements have acceptable safety profiles. The primary endpoint of this trial will be a composite of all cause mortality, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, and hospitalization for angina. Approximately 120 sites will enroll 2372 patients 50 years of age or older with a prior MI. Following baseline assessments, patients will be randomly assigned to receive 40 infusions of either chelation or placebo solution, administered as 30 weekly infusions followed by 10 bi-monthly infusions. In this 2x2 factorial design, each of these groups (chelation and placebo) will also be randomized to either high-dose supplements or low-dose supplements (for a total of four treatment groups). The chelation/placebo solution will be administered intravenously over three hours. The low-dose/high-dose supplements are administered orally and to be taken daily. Scheduled labs will be drawn prior to the beginning of infusions 2, 5, 10, 15, 20, 25, 30, 36, and 40. After treatment, subjects will have 3 telephone follow-ups and one clinic visit annually until the completion of the entire study (an average of 2.5 years). Subjects may receive all infusions at the GCRC on an outpatient basis.
Showing the most recent 10 out of 753 publications
