Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1708 participants
INTERVENTIONAL
2003-09-30
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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EDTA + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
EDTA
Participants will receive 40 infusions of standard chelation solution.
High Dose Vitamin
EDTA + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
EDTA
Participants will receive 40 infusions of standard chelation solution.
High Dose Vitamin Placebo
EDTA placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
EDTA Placebo
Participants will receive 40 infusions of EDTA placebo.
High Dose Vitamin
EDTA placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
EDTA Placebo
Participants will receive 40 infusions of EDTA placebo.
High Dose Vitamin Placebo
Interventions
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EDTA
Participants will receive 40 infusions of standard chelation solution.
EDTA Placebo
Participants will receive 40 infusions of EDTA placebo.
High Dose Vitamin
High Dose Vitamin Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Platelet count less than 100,000/µL
* Blood pressure greater than 160/100
* Chelation therapy within 5 years prior to study start
* History of allergic reactions to EDTA or any of the therapy's components
* Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
* Cigarette smoking within 3 months prior to study start
* Childbearing potential
* History of liver disease
* Active heart failure or heart failure hospitalization within 6 months.
* Diagnoses of additional medical conditions that could otherwise limit patient survival
* Inability to tolerate 500-mL infusions weekly.
50 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Mt. Sinai Medical Center, Miami
OTHER
Responsible Party
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Gervasio Lamas, MD
Chair, Department of Medicine- Chief, Division of Cardiology
Principal Investigators
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Gervasio A Lamas, M.D.
Role: STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai
Locations
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Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mt Holistic Health Center
Danville, California, United States
Patrick A. Golden
Fresno, California, United States
Scripps Center for Integrative Medicine
La Jolla, California, United States
Phoenix Wellness Group
Napa, California, United States
Aurora Denver Cardiology Associates
Denver, Colorado, United States
The Blend Institute
Bradenton, Florida, United States
Wellness Works
Brandon, Florida, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Hyperbaric Medicine Inc.
Fort Walton Beach, Florida, United States
White-Wilson Medical Center
Fort Walton Beach, Florida, United States
Tru Med
Melbourne, Florida, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Tri-Health Alternative Medical Center
Mt. Dora, Florida, United States
Heart and Vascular Center for Research, Inc.
Sarasota, Florida, United States
Florida Cardiovascular Institute
Tampa, 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
Emory University School of Medicine
Atlanta, Georgia, United States
Full Circle Medical Center
Fort Oglethorpe, Georgia, United States
Crossroads Healing Arts LLC
Goshen, Indiana, United States
Integrative Medical Center at Schneck Medical Center
Seymour, Indiana, United States
Northwest Indiana Cardiovascular Physicians Inc.
Valparaiso, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
The Center for the Improvement of Functioning International
Wichita, Kansas, United States
Complementary Medical Services
Mandeville, Louisiana, United States
Maine Integrative Wellness
Portland, Maine, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Marino Center for Progressive Health
Cambridge, Massachusetts, United States
Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine
Detroit, Michigan, 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
University of Missouri Hospital and Clinics
Columbia, Missouri, 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
Magaziner Center for Wellness
Cherry Hill, New Jersey, United States
Park Professional Building
Roselle Park, New Jersey, United States
Stockton Family Practice
Stockton, New Jersey, United States
Heart Care Center
East Syracuse, New York, United States
The Gables Natural Medicines Center & Day Spa Family Health Services
Mayville, New York, United States
NYU School of Medicine
New York, New York, United States
Rhinebeck Health Center
Rhinebeck, New York, United States
Staten Island Heart
Staten Island, New York, United States
Schachter Center for Complementary Medicine
Suffern, New York, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, United States
Integrative Medical Associates, PLLC
Tryon, North Carolina, United States
Celebration of Health Center
Bluffton, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Comprehensive Heart Care, Inc.
Toledo, Ohio, United States
Upper Valley Family Care
Troy, Ohio, United States
COR Research
Oklahoma City, Oklahoma, United States
St. Charles Health System
Bend, Oregon, United States
Center for Environmental Medicine
Portland, Oregon, United States
Wholistic Health Center
Greensburg, Pennsylvania, United States
Woodlands Healing Research Center
Quakertown, Pennsylvania, United States
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States
Biogenesis Medical Center
Landrum, South Carolina, United States
Athens Surgery Clinic
Athens, Tennessee, United States
The Castle Clinic, PLLC
Johnson City, Tennessee, United States
Chelation Centers of Texas
Texas City, Texas, United States
Freedom Center for Advanced Medicine
Provo, Utah, United States
The Cardiovascular Group
Fairfax, Virginia, United States
Virginia Beach General Hospital
Virginia Beach, Virginia, United States
Hope Medical Holistic Clinic
Vancouver, Washington, United States
Care Foundation Inc.
Wausau, Wisconsin, United States
Waters Preventive Medical Center, LTD
Wisconsin Dells, Wisconsin, United States
Cline Medical Centre
Nanaimo, British Columbia, Canada
The Wellness Centre
Port Hawkesbury, Nova Scotia, Canada
Chelation Center of Barrie, Inc.
Barrie, Ontario, Canada
Anti-Aging & Family Wellness Clinic
Madoc, Ontario, Canada
Markham Integrative Medicine
Markham, Ontario, Canada
North Bay Complementary
North Bay, Ontario, Canada
Seekers Centre for Integrative Medicine
Ottawa, Ontario, Canada
Dr. C. Minielly
Smith Falls, Ontario, Canada
Chelation Center of Don Valley Inc.
Toronto, Ontario, Canada
Jaconello Health Centre
Toronto, Ontario, Canada
Chelation and Natural Therapy
Toronto, Ontario, Canada
Chelox
Toronto, Ontario, Canada
Saskatoon Chelation Centre
Saskatoon, Saskatchewan, Canada
Countries
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References
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