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| Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00044213 |
Purpose
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 |
|
Coronary Artery Disease |
Drug: EDTA chelation therapy |
Phase III |
| MedlinePlus related topics: | Coronary Artery Disease |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
| Official Title: | Trial to Assess Chelation Therapy (TACT) |
| Estimated Enrollment: | 1950 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | July 2009 |
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.
Eligibility
| 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:
Contacts and Locations| Contact: NCCAM Clearinghouse | 1-888-644-6226 |
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Show 163 Study Locations |
| National Center for Complementary and Alternative Medicine (NCCAM) |
| National Heart, Lung, and Blood Institute (NHLBI) |
| Study Director: | Anthony Lamas, M.D. | Mt. Sinai Medical Center of Florida |
More Information
View the NIH press release and Q & A regarding the study from here. 
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Sites are being added frequently; click here to view a current list from the NCCAM web site. 
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| Study ID Numbers: | U01 AT001156-01 |
| First Received: | August 22, 2002 |
| Last Updated: | September 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00044213 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
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