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Trial to Assess Chelation Therapy (TACT)
This study is currently recruiting patients.
| Sponsored by: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
Purpose
This study is being conducted to determine the safety and efficacy of EDTA chelation therapy in individuals with coronary artery disease.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Coronary Artery Disease |
Drug: EDTA chelation therapy |
Phase III |
MedlinePlus related topics: Coronary Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Expected Total Enrollment: 2372
Study start: March 2003
This study is a multi-center randomized clinical trial 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 conducting 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. 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;
(5) health-related quality-of-life;
(6) cost and cost-effectiveness;
(7) brachial artery flow-mediated endothelial function;
(8) plasma markers of oxidative stress and anti-oxidant protection; and
(9) plasma markers of endothelial activation and inflammation.
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 above, Genders Eligible for Study: Both
Criteria
For Patients:
Participants must be 50 years of age or older, have had a heart attack at least 6 weeks prior to evaluation, and have not had chelation therapy within the past 5 years. Other exclusion criteria include:
History of allergic reactions to EDTA or any of the therapy's components Coronary or carotid revascularization procedures within the past 6 months or a scheduled revascularization History of cigarette smoking within the last 3 months Childbearing potential History of liver disease Diagnoses of additional medical conditions that could otherwise limit patient survival, such as cancer.
The goal is to recruit a patient study population of both men and women that is fairly typical of people with CAD. The study investigators also will recruit participants whose ethnic and racial makeup reflects the diversity of the United States population.
For Health Care Professionals:
Inclusion Criteria
All of the following inclusion criteria must be present for the patient to be enrolled in the trial.
1. Men or women age 50 years and older (women must be post-menopausal).
2. Documented myocardial infarction (MI) over 6 weeks prior to evaluation. The criteria for MI will be based on the ESC/ACC definition as follows:
Either of the following criteria (A or B):
A. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK- MB) of biochemical markers of myocardial necrosis with at least one of the following:
1) Ischemic symptoms;
2) Development of pathologic Q waves on the electrocardiogram (ECG); or
3) ECG changes indicative of ischemia (ST-segment elevation or depression);or
B. Imaging evidence of myocardial scar, and coronary angiographic evidence of epicardial coronary disease in the same distribution. A prior MI may be diagnosed in patients with angiographically defined coronary artery disease (a luminal narrowing >50% of a major epicardial coronary artery) and imaging evidence of myocardial scar in the anatomically corresponding distribution. Imaging evidence of myocardial scar includes a non-reversible perfusion defect on myocardial radionuclide perfusion imaging or severe wall motion abnormality on contrast angiography, radionuclide angiography, or echocardiography.
Exclusion Criteria
In order for patients to be enrolled in the trial, none of the following exclusion criteria may be present.
Location
and Contact
Information
More Information
View the NIH press release and Q & A regarding the study from here.
Sites are being added frequently; click here to view a current list from the NCCAM web site.
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