In response to the Request for Application (AT-01-004) released by NCCAM, we are proposing a multi-center randomized clinical trial (Trial to Assess Chelation Therapy [TACT]) in 1600 patients age 50 or older comparing 40 infusions of the standard chelation solution recommended by the American College for Advancement in Medicine versus 40 infusions of placebo. Chelation therapy, as practiced in the community, also includes the use of high dose antioxidant vitamin and mineral supplements. Thus, any clinical benefit of chelation therapy may be due either to the effect of EDTA chelation, or high dose supplements, or both. Therefore, we are further proposing a 2X2 factorial design to independently test the effects of a high-dose supplementation, versus a low dose regimen to simply replace chelation-related losses. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure. This primary endpoint is consistent with the RFA. TACT will have over 90 percent power to detect a 25 percent reduction, and over 80 percent power to detect a 20 percent reduction in this primary endpoint. Major secondary endpoints will include (1) a combined endpoint of cardiac death, or nonfatal myocardial infarction, or nonfatal stroke; (2) the individual components of the primary endpoint; (3) coronary revascularization; (4) safety of the interventions including indices of renal, hepatic, and hematological function, as suggested by the RFA; (5) health-related quality-of-life; (6) cost and cost-effectiveness, as suggested by the RFA; (7) brachial artery flow-mediated endothelial function, as suggested by the RFA; (8) plasma markers of oxidative stress and anti-oxidant protection, as suggested by the RFA; and (9) plasma markers of endothelial activation and inflammation, as suggested by the RFA. The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL092607-07
Application #
7483180
Study Section
Special Emphasis Panel (ZAT1-K (02))
Program Officer
Boineau, Robin
Project Start
2002-08-15
Project End
2008-05-31
Budget Start
2008-03-01
Budget End
2008-05-31
Support Year
7
Fiscal Year
2008
Total Cost
$929,729
Indirect Cost
Name
Mount Sinai Medical Center (Miami Beach)
Department
Type
DUNS #
046025144
City
Miami Beach
State
FL
Country
United States
Zip Code
33140
Lamas, Gervasio A; Navas-Acien, Ana; Mark, Daniel B et al. (2016) Heavy Metals, Cardiovascular Disease, and the Unexpected Benefits of Chelation Therapy. J Am Coll Cardiol 67:2411-2418
Lamas, Gervasio A; Issa, Omar M (2016) Edetate Disodium-Based Treatment for Secondary Prevention in Post-Myocardial Infarction Patients. Curr Cardiol Rep 18:20
Lamas, Gervasio A; Ergui, Ian (2016) Chelation therapy to treat atherosclerosis, particularly in diabetes: is it time to reconsider? Expert Rev Cardiovasc Ther 14:927-38
Lamas, Gervasio A (2015) Cardiology Patient Page. Chelation therapy: a new look at an old treatment for heart disease, particularly in diabetics. Circulation 131:e505-6
Mark, Daniel B; Anstrom, Kevin J; Clapp-Channing, Nancy E et al. (2014) Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes 7:508-16
Avila, Maria D; Escolar, Esteban; Lamas, Gervasio A (2014) Chelation therapy after the trial to assess chelation therapy: results of a unique trial. Curr Opin Cardiol 29:481-8
Lamas, Gervasio A; Boineau, Robin; Goertz, Christine et al. (2014) EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J 168:37-44.e5
Escolar, Esteban; Lamas, Gervasio A; Mark, Daniel B et al. (2014) The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes 7:15-24
Solenkova, Natalia V; Newman, Jonathan D; Berger, Jeffrey S et al. (2014) Metal pollutants and cardiovascular disease: mechanisms and consequences of exposure. Am Heart J 168:812-22
Lamas, Gervasio A; Goertz, Christine; Boineau, Robin et al. (2013) Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA 309:1241-50

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