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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00044213 |
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: EDTA chelation therapy Drug: Placebo infusions |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Trial to Assess Chelation Therapy (TACT) |
Estimated Enrollment: | 1950 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive 40 infusions of standard chelation solution.
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Drug: EDTA chelation therapy
Participants will receive 40 infusions of standard chelation solution.
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2: Placebo Comparator
Participants will receive 40 infusions of placebo.
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Drug: Placebo infusions
Participants will receive 40 infusions of placebo.
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EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.
Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. 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.
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Participants:
Exclusion Criteria for Participants:
Contact: NCCAM Clearinghouse | 1-888-644-6226 |
Study Director: | Gervasio A Lamas, M.D. | University of Miami |
Responsible Party: | University of Miami School of Medicine ( Gervasio A. Lamas, MD ) |
Study ID Numbers: | U01 HL092607 |
Study First Received: | August 22, 2002 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00044213 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |