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Trial to Assess Chelation Therapy (TACT)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00044213
First received: August 22, 2002
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  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
Drug: Placebo infusions
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Trial to Assess Chelation Therapy (TACT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:
  • A composite of total mortality, recurrent myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 1708
Study Start Date: September 2003
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EDTA chelation + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
 Drug: EDTA chelation therapy
Participants will receive 40 infusions of standard chelation solution.
Placebo Comparator: EDTA chelation + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
 Drug: Placebo infusions
Participants will receive 40 infusions of placebo.
Placebo Comparator: EDTA chelation placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Placebo Comparator: EDTA chelation placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Participants:

  • Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

  • 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
  • Diagnoses of additional medical conditions that could otherwise limit patient survival
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044213

  Hide Study Locations
Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Mt Holistic Health Center
Danville, California, United States, 94526
Patrick A. Golden
Fresno, California, United States, 93720
Scripps Center for Integrative Medicine
La Jolla, California, United States, 92037
Phoenix Wellness Group
Napa, California, United States, 94558
United States, Colorado
Aurora Denver Cardiology Associates
Denver, Colorado, United States, 80218
United States, Florida
The Blend Institute
Bradenton, Florida, United States, 34221
Wellness Works
Brandon, Florida, United States, 33510
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
White-Wilson Medical Center
Fort Walton Beach, Florida, United States, 32547
Hyperbaric Medicine Inc.
Ft. Walton Beach, Florida, United States, 32547
Tru Med
Melbourne, Florida, United States, 32901
Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33176
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Tri-Health Alternative Medical Center
Mt. Dora, Florida, United States, 32757
Heart and Vascular Center for Research, Inc.
Sarasota, Florida, United States, 34239
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
Life Family Practice Center for Complementary and Alternative Medicine
The Villages, Florida, United States, 32159
Florida Medical Clinic, P.A. Clinical Research Division
Zephyrhills, Florida, United States, 33542
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Full Circle Medical Center
Fort Oglethorpe, Georgia, United States, 30742
United States, Indiana
Crossroads Healing Arts LLC
Goshen,, Indiana, United States, 46528
Integrative Medical Center at Schneck Medical Center
Seymour, Indiana, United States, 47274
Northwest Indiana Cardiovascular Physicians Inc.
Valparaiso, Indiana, United States, 46383
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
The Center for the Improvement of Functioning International
Wichita, Kansas, United States, 67219
United States, Louisiana
Complementary Medical Services
Mandeville, Louisiana, United States, 70471
United States, Maine
Maine Integrative Wellness
Portland, Maine, United States, 04103
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Marino Center for Progressive Health
Cambridge, Massachusetts, United States, 02140
United States, Michigan
Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine
Detroit, Michigan, United States, 48202
The Preventive Medicine Center
Flint, Michigan, United States, 48503
Born Preventive Health Care Clinic
Grand Rapids, Michigan, United States, 49512
Parchment Family Practice
Kalamazoo,, Michigan, United States, 49004
United States, Minnesota
Berman Center for Outcomes and Clinical Research
Minneapolis, Minnesota, United States, 55404
Mayo Clinic and Foundation Cardiovascular Health Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65201
Brian Dieterle, MD, PhD
Hollister, Missouri, United States, 65673
Preventive Medicine
St. Louis, Missouri, United States, 63146
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Magaziner Center for Wellness
Cherry Hill, New Jersey, United States, 08003
Park Professional Building
Roselle Park, New Jersey, United States, 07204
Stockton Family Practice
Stockton, New Jersey, United States, 08559
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10457
Heart Care Center
East Syracuse, New York, United States, 13057
The Gables Natural Medicines Center & Day Spa Family Health Services
Mayville, New York, United States, 14757
NYU School of Medicine
New York, New York, United States, 10016
Rhinebeck Health Center
Rhinebeck, New York, United States, 12572
Staten Island Heart
Staten Island, New York, United States, 10305
Schachter Center for Complementary Medicine
Suffern, New York, United States, 10901
United States, North Carolina
Integrative Medical Associates, PLLC
Tryon, North Carolina, United States, 28782
United States, Ohio
Celebration of Health Center
Bluffton, Ohio, United States, 45817
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Comprehensive Heart Care, Inc.
Toledo, Ohio, United States, 43606
Upper Valley Family Care
Troy, Ohio, United States, 45373
United States, Oklahoma
COR Research
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
St. Charles Health System
Bend, Oregon, United States, 97701
Center for Environmental Medicine
Portland, Oregon, United States, 97220
United States, Pennsylvania
Wholistic Health Center
Greensburg, Pennsylvania, United States, 15601
Woodlands Healing Research Center
Quakertown, Pennsylvania, United States, 18951
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Biogenesis Medical Center
Landrum, South Carolina, United States, 29356
United States, Tennessee
Athens Surgery Clinic
Athens, Tennessee, United States, 37303
The Castle Clinic, PLLC
Johnson City, Tennessee, United States, 37601
United States, Texas
Chelation Centers of Texas
Texas City, Texas, United States, 77591
United States, Utah
Freedom Center for Advanced Medicine
Provo, Utah, United States, 84604
United States, Virginia
The Cardiovascular Group
Fairfax, Virginia, United States, 22031
Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Hope Medical Holistic Clinic
Vancouver, Washington, United States, 98663
United States, Wisconsin
Care Foundation Inc.
Wausau, Wisconsin, United States, 54401
Waters Preventive Medical Center, LTD
Wisconsin Dells, Wisconsin, United States, 53965
Canada, British Columbia
Cline Medical Centre
Nanaimo, British Columbia, Canada, V9R 2M9
Canada, Nova Scotia
The Wellness Centre
Port Hawkesbury, Nova Scotia, Canada, V4P 1B5
Canada, Ontario
Chelation Center of Barrie, Inc.
Barrie, Ontario, Canada, L4N9T6
Anti-Aging & Family Wellness Clinic
Madoc, Ontario, Canada, K0K 2K0
Markham Integrative Medicine
Markham, Ontario, Canada, L3P 1Y8
North Bay Complementary
North Bay, Ontario, Canada, P1B 4B8
Seekers Centre for Integrative Medicine
Ottawa, Ontario, Canada, K2E 1B3
Dr. C. Minielly
Smith Falls, Ontario, Canada, K7A 1C3
Chelox
Toronto, Ontario, Canada, M6H 3M2
Chelation and Natural Therapy
Toronto, Ontario, Canada, M4W 3T1
Jaconello Health Centre
Toronto, Ontario, Canada, M4K 3T1
Chelation Center of Don Valley Inc.
Toronto, Ontario, Canada, M3C3F2
Canada, Saskatchewan
Saskatoon Chelation Centre
Saskatoon, Saskatchewan, Canada, S7M 5W1
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Study Director: Gervasio A Lamas, M.D. Mount Sinai School of Medicine
  More Information

Additional Information:
View the NIH press release and Q & A regarding the study from here.  This link exits the ClinicalTrials.gov site

No publications provided by Mt. Sinai Medical Center, Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gervasio Lamas, MD, Chair, Department of Medicine- Chief, Division of Cardiology, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00044213     History of Changes
Other Study ID Numbers: 654, U01HL092607, U01AT001156
Study First Received: August 22, 2002
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chelating Agents
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Edetic Acid
 Vitamins
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013