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Home > "T" Clinical Trials Conditions > Trial to Assess Chelation Therapy (TACT)  Trial to Assess Chelation Therapy (TACT)
Trial to Assess Chelation Therapy (TACT)
For Condition: Coronary Artery Disease
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , National Heart, Lung, and Blood Institute (NHLBI)
Synopsis: This study is being conducted to determine the safety and efficacy of EDTA chelation therapy in individuals with coronary artery disease.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry 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. - Prior chelation therapy within 5 years of proposed randomization date. - History of allergic reactions to any of the components of the chelation solution (see description of chelation solution) or the vitamins and minerals. - Coronary or carotid revascularization procedure within the last 6 months. - Planned revascularization. - Symptomatic heart failure at proposed time of enrollment. - Clinically evident heart failure, visible symptomatic volume overload, in the opinion of the treating physician. - Hospitalization for heart failure within 6 months. - Stage II hypertension is defined in the JNC6 guidelines as a blood pressure >160/100. If blood pressure > 160/100, then the patient may be treated and reevaluated for enrollment at a future date. - No venous access in the upper extremities. - Baseline serum creatinine >2.0 mg/dl. - Baseline platelet count <100,000/mm. - History of cigarette smoking within the last 3 months. - History of liver disease. - ALT or AST > 2.0 times the upper limit of normal. - Diseases of copper (Wilson’s Disease), iron (hemochromatosis, iron deficiency), or calcium (calcium < 8.0mg/dl) metabolism. - Inability to tolerate the weekly fluid load (500cc of normal saline). - Any condition or circumstance such as chronic non-compliance or an itinerant lifestyle that will affect compliance with the study interventions. - Any severe, non-coronary medical condition likely to affect patient survival within 4 years. - Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization.
Total Enrollment: 2372
Location and Contact Information:
Wellness and Longevity Center of Louisiana *Recruiting*
Lafayette, Louisiana, 70508
United States
Recruiting
Magaziner Center for Wellness *Recruiting*
Cherry Hill, New Jersey, 08003
United States
Recruiting
Complementary Medical Services *Recruiting*
Mandeville, Louisiana, 70471
United States
Recruiting
The Cardiovascular Group *Recruiting*
Fairfax, Virginia, 22031
United States
Recruiting
Florida Cardiovascular Group - Research *Recruiting*
Atlantis, Florida,
United States
Recruiting
Androsloggin Cardiology Associates *Recruiting*
Auburn, Maine, 04210
United States
Recruiting
Boice Willis Clinic *Recruiting*
Rocky Mount, North Carolina, 27801
United States
Recruiting
The Ohio State University Medical Center *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting
Kansas University Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting
Kenneth Ganapini, M.D. *Recruiting*
Flint, Michigan, 48532
United States
Recruiting
Bronx-Lebanon Hospital Center *Recruiting*
Bronx, New York, 10456
United States
Recruiting
Total Sensory Wellness Center *Recruiting*
Waldorf, Maryland, 20602
United States
Recruiting
The Camelot Foundation *Recruiting*
Omaha, Nebraska, 68114
United States
Recruiting
Evanston Northwestern Healthcare *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting
Born Preventive Health Care Clinic *Recruiting*
Grand Rapids, Michigan, 49512
United States
Recruiting
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27708
United States
Recruiting
Tru Med *Recruiting*
Melbourne, Florida, 32901
United States
Recruiting
1005 DR D.B. Todd Boulevard *Recruiting*
Nashville, Tennessee, 37208
United States
Recruiting
Waters Preventive Medical Center, LTD *Recruiting*
Wisconsin Dells, Wisconsin, 53965
United States
Recruiting
Casdorph Clinic *Recruiting*
Long Beach, California, 90804
United States
Recruiting
Complementary Medical Services *Recruiting*
Metairie, Louisiana, 70002
United States
Recruiting
Mark O'Neil Speight, M.D. *Recruiting*
Charlotte, North Carolina, 28202
United States
Recruiting
Innovative Research of West Florida *Recruiting*
Largo, Florida, 33770
United States
Recruiting
St. Louis Heart and Vascular *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Miami Heart Research Institute *Recruiting*
Miami, Florida, 33140
United States
Recruiting
Caring Cardiology *Recruiting*
Miami, Florida,
United States
Recruiting
Aurora Denver Cardiology Associates *Recruiting*
Denver, Colorado, 80020
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting
Grace Medical Association *Recruiting*
Lewisville, Texas, 75057
United States
Recruiting
Heart and Vascular Center for Research, Inc. *Recruiting*
Sarasota, Florida, 34239
United States
Recruiting
Ana M. Lamas, M.D. *Recruiting*
Miami, Florida,
United States
Recruiting
The Institute of Integrative Medicine *Recruiting*
Denville, New Jersey, 07834
United States
Recruiting
Advanced Concepts in Medicine *Recruiting*
Cornelius, North Carolina, 28031
United States
Recruiting
Preventive Medicine *Recruiting*
St. Louis, Missouri, 63146
United States
Recruiting
Crescent City Clinical Services *Recruiting*
New Orleans, Louisiana, 70115
United States
Recruiting
Southwest Florida Heart Group *Recruiting*
Ft. Myers, Florida, 33919
United States
Recruiting
Arnold Good, M.D. *Recruiting*
Columbus, Ohio, 43215
United States
Recruiting
Advantage Health Center, LLC *Recruiting*
Myrtle Beach, South Carolina, 29588
United States
Recruiting
Baystate Medical Center *Recruiting*
Springfield, Massachusetts, 01103
United States
Recruiting
The Broward Heart Group, P.A. *Recruiting*
Tamarac, Florida, 33321
United States
Recruiting
Yulius Poplyansky, M.D. *Recruiting*
Roselle Park, New Jersey, 07204
United States
Recruiting
Freedom Center for Advanced Medicine *Recruiting*
Provo, Utah, 84604
United States
Recruiting
Stockton Family Practice *Recruiting*
Stockton, New Jersey, 08559
United States
Recruiting
Johns Hopkins Bayview Medical Center *Recruiting*
Baltimore, Maryland, 21224
United States
Recruiting
Heart Care Center *Recruiting*
East Syracuse, New York, 13057
United States
Recruiting
Virginia Beach General Hospital *Recruiting*
Virginia Beach, Virginia, 23454
United States
Recruiting
University of Missouri Hospital and Clinics *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting
David Strassberg, M.D. *Recruiting*
Woodbridge, New Jersey, 07095
United States
Recruiting
Central Arkansas Veterans Healthcare System *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting
Family Health Care Center *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting
Pain and Healing Center *Recruiting*
Miami, Florida, 33166
United States
Recruiting
Biogenesis Medical Center *Recruiting*
Landrum, South Carolina, 29356
United States
Recruiting
University Hospitals of Cleveland *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting
Patrick A. Golden *Recruiting*
Fresno, California, 93720
United States
Recruiting
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting
Center for Health Enrichment *Recruiting*
Plymouth, Indiana, 46563
United States
Recruiting
Schachter Center for Complementary Medicine *Recruiting*
Suffern, New York, 10901
United States
Recruiting
Additional Information:
Study ID Numbers: 1 U01 AT001156-01;
Study Start Date: March 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044213
Other Coronary Artery Disease Studies:
1. A Phase III study for the prevention of autogenous vein graft failure in coronary artery bypass procedures
2. Autologous Cultured Myoblasts (BioWhittaker) Transplanted via Myocardial Injection
3. ARISE - Aggressive Reduction of Inflammation Stops Events
4. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)
5. Trial to Assess Chelation Therapy (TACT)
Related Studies:
Other Coronary Artery Disease Clinical Trials
Other Florida Clinical Trials
Other Sarasota Clinical Trials
Trial to Assess Chelation Therapy (TACT)
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