Trial to Assess Chelation Therapy (TACT)
- Conditions
- Coronary Artery Disease
- Interventions
- Dietary Supplement: High Dose VitaminDietary Supplement: High Dose Vitamin Placebo
- Registration Number
- NCT00044213
- Lead Sponsor
- Mt. Sinai Medical Center, Miami
- Brief Summary
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.
- Detailed Description
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, coronary revascularization, and hospitalization for angina.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1708
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description EDTA placebo + high dose vitamin placebo EDTA Placebo Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. EDTA + high dose vitamin High Dose Vitamin Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. EDTA + high dose vitamin placebo High Dose Vitamin Placebo Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. EDTA placebo + high dose vitamin EDTA Placebo Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. EDTA placebo + high dose vitamin High Dose Vitamin Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. EDTA placebo + high dose vitamin placebo High Dose Vitamin Placebo Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. EDTA + high dose vitamin EDTA Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. EDTA + high dose vitamin placebo EDTA Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
- Primary Outcome Measures
Name Time Method A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. Measured over a maximum 5-year follow-up period- 55 month median Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.
- Secondary Outcome Measures
Name Time Method A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. Measured over a maximum 5-year follow-up period- 55 month median Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.
Trial Locations
- Locations (86)
Saskatoon Chelation Centre
🇨🇦Saskatoon, Saskatchewan, Canada
The Blend Institute
🇺🇸Bradenton, Florida, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States
Maine Integrative Wellness
🇺🇸Portland, Maine, United States
The Cardiovascular Group
🇺🇸Fairfax, Virginia, United States
Heart Care Center
🇺🇸East Syracuse, New York, United States
Chelation and Natural Therapy
🇨🇦Toronto, Ontario, Canada
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Baptist Cardiac & Vascular Institute
🇺🇸Miami, Florida, United States
Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine
🇺🇸Detroit, Michigan, United States
Center for Environmental Medicine
🇺🇸Portland, Oregon, United States
Integrative Medical Center at Schneck Medical Center
🇺🇸Seymour, Indiana, United States
Tru Med
🇺🇸Melbourne, Florida, United States
Mt Holistic Health Center
🇺🇸Danville, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Scripps Center for Integrative Medicine
🇺🇸La Jolla, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
White-Wilson Medical Center
🇺🇸Fort Walton Beach, Florida, United States
Hyperbaric Medicine Inc.
🇺🇸Ft. Walton Beach, Florida, United States
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Phoenix Wellness Group
🇺🇸Napa, California, United States
Patrick A. Golden
🇺🇸Fresno, California, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Full Circle Medical Center
🇺🇸Fort Oglethorpe, Georgia, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Seekers Centre for Integrative Medicine
🇨🇦Ottawa, Ontario, Canada
University of Missouri Hospital and Clinics
🇺🇸Columbia, Missouri, United States
Magaziner Center for Wellness
🇺🇸Cherry Hill, New Jersey, United States
The Gables Natural Medicines Center & Day Spa Family Health Services
🇺🇸Mayville, New York, United States
Staten Island Heart
🇺🇸Staten Island, New York, United States
Upper Valley Family Care
🇺🇸Troy, Ohio, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Bronx-Lebanon Hospital Center
🇺🇸Bronx, New York, United States
Stockton Family Practice
🇺🇸Stockton, New Jersey, United States
Athens Surgery Clinic
🇺🇸Athens, Tennessee, United States
Comprehensive Heart Care, Inc.
🇺🇸Toledo, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
St. Charles Health System
🇺🇸Bend, Oregon, United States
Woodlands Healing Research Center
🇺🇸Quakertown, Pennsylvania, United States
Celebration of Health Center
🇺🇸Bluffton, Ohio, United States
The Castle Clinic, PLLC
🇺🇸Johnson City, Tennessee, United States
Biogenesis Medical Center
🇺🇸Landrum, South Carolina, United States
COR Research
🇺🇸Oklahoma City, Oklahoma, United States
Freedom Center for Advanced Medicine
🇺🇸Provo, Utah, United States
Markham Integrative Medicine
🇨🇦Markham, Ontario, Canada
Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
The Wellness Centre
🇨🇦Port Hawkesbury, Nova Scotia, Canada
Anti-Aging & Family Wellness Clinic
🇨🇦Madoc, Ontario, Canada
Dr. C. Minielly
🇨🇦Smith Falls, Ontario, Canada
Aurora Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
Care Foundation Inc.
🇺🇸Wausau, Wisconsin, United States
Jaconello Health Centre
🇨🇦Toronto, Ontario, Canada
North Bay Complementary
🇨🇦North Bay, Ontario, Canada
Heart and Vascular Center for Research, Inc.
🇺🇸Sarasota, Florida, United States
Chelation Center of Don Valley Inc.
🇨🇦Toronto, Ontario, Canada
Rhinebeck Health Center
🇺🇸Rhinebeck, New York, United States
Integrative Medical Associates, PLLC
🇺🇸Tryon, North Carolina, United States
Chelox
🇨🇦Toronto, Ontario, Canada
Wellness Works
🇺🇸Brandon, Florida, United States
Tri-Health Alternative Medical Center
🇺🇸Mt. Dora, Florida, United States
Life Family Practice Center for Complementary and Alternative Medicine
🇺🇸The Villages, Florida, United States
Florida Medical Clinic, P.A. Clinical Research Division
🇺🇸Zephyrhills, Florida, United States
Crossroads Healing Arts LLC
🇺🇸Goshen,, Indiana, United States
The Center for the Improvement of Functioning International
🇺🇸Wichita, Kansas, United States
Northwest Indiana Cardiovascular Physicians Inc.
🇺🇸Valparaiso, Indiana, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Complementary Medical Services
🇺🇸Mandeville, Louisiana, United States
Marino Center for Progressive Health
🇺🇸Cambridge, Massachusetts, United States
The Preventive Medicine Center
🇺🇸Flint, Michigan, United States
Born Preventive Health Care Clinic
🇺🇸Grand Rapids, Michigan, United States
Parchment Family Practice
🇺🇸Kalamazoo,, Michigan, United States
Berman Center for Outcomes and Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic and Foundation Cardiovascular Health Clinic
🇺🇸Rochester, Minnesota, United States
Brian Dieterle, MD, PhD
🇺🇸Hollister, Missouri, United States
Preventive Medicine
🇺🇸St. Louis, Missouri, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Park Professional Building
🇺🇸Roselle Park, New Jersey, United States
Schachter Center for Complementary Medicine
🇺🇸Suffern, New York, United States
Wholistic Health Center
🇺🇸Greensburg, Pennsylvania, United States
Chelation Centers of Texas
🇺🇸Texas City, Texas, United States
Main Line Health Heart Center
🇺🇸Wynnewood, Pennsylvania, United States
Hope Medical Holistic Clinic
🇺🇸Vancouver, Washington, United States
Cline Medical Centre
🇨🇦Nanaimo, British Columbia, Canada
Waters Preventive Medical Center, LTD
🇺🇸Wisconsin Dells, Wisconsin, United States
Chelation Center of Barrie, Inc.
🇨🇦Barrie, Ontario, Canada
Florida Cardiovascular Institute
🇺🇸Tampa, Florida, United States