Trial to Assess Chelation Therapy (TACT)
Trial to Assess Chelation Therapy (TACT)
Sponsors
Source
Mt. Sinai Medical Center, Miami
Oversight Info
Has Dmc
Yes
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.
Overall Status
Completed
Start Date
2003-09-01
Completion Date
2012-08-01
Primary Completion Date
2011-10-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
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 |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
1708
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Participants will receive 40 infusions of standard chelation solution.
Arm Group Label
EDTA + high dose vitamin
EDTA + high dose vitamin placebo
Intervention Type
Drug
Intervention Name
Description
Participants will receive 40 infusions of EDTA placebo.
Arm Group Label
EDTA placebo + high dose vitamin
EDTA placebo + high dose vitamin placebo
Intervention Type
Dietary Supplement
Intervention Name
Arm Group Label
EDTA + high dose vitamin
EDTA placebo + high dose vitamin
Intervention Type
Dietary Supplement
Intervention Name
Arm Group Label
EDTA + high dose vitamin placebo
EDTA placebo + high dose vitamin placebo
Eligibility
Criteria
Inclusion Criteria for Participants:
- Heart attack at least 6 weeks prior to study start
Exclusion Criteria for Participants:
- Serum creatinie level greater than 2.0 mg/dL
- 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.
Gender
All
Minimum Age
50 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Gervasio A Lamas, M.D. |
Study Director |
Icahn School of Medicine at Mount Sinai |
Location
Facility |
|
Central Arkansas Veterans Healthcare System Little Rock Arkansas 72205 United States |
|
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 United States |
|
Mt Holistic Health Center Danville California 94526 United States |
|
Patrick A. Golden Fresno California 93720 United States |
|
Scripps Center for Integrative Medicine La Jolla California 92037 United States |
|
Phoenix Wellness Group Napa California 94558 United States |
|
Aurora Denver Cardiology Associates Denver Colorado 80218 United States |
|
The Blend Institute Bradenton Florida 34221 United States |
|
Wellness Works Brandon Florida 33510 United States |
|
Innovative Research of West Florida Clearwater Florida 33756 United States |
|
White-Wilson Medical Center Fort Walton Beach Florida 32547 United States |
|
Hyperbaric Medicine Inc. Ft. Walton Beach Florida 32547 United States |
|
Tru Med Melbourne Florida 32901 United States |
|
Mount Sinai Medical Center Miami Beach Florida 33140 United States |
|
Baptist Cardiac & Vascular Institute Miami Florida 33176 United States |
|
Tri-Health Alternative Medical Center Mt. Dora Florida 32757 United States |
|
Heart and Vascular Center for Research, Inc. Sarasota Florida 34239 United States |
|
Florida Cardiovascular Institute Tampa Florida 33609 United States |
|
Life Family Practice Center for Complementary and Alternative Medicine The Villages Florida 32159 United States |
|
Florida Medical Clinic, P.A. Clinical Research Division Zephyrhills Florida 33542 United States |
|
Emory University School of Medicine Atlanta Georgia 30303 United States |
|
Full Circle Medical Center Fort Oglethorpe Georgia 30742 United States |
|
Crossroads Healing Arts LLC Goshen, Indiana 46528 United States |
|
Integrative Medical Center at Schneck Medical Center Seymour Indiana 47274 United States |
|
Northwest Indiana Cardiovascular Physicians Inc. Valparaiso Indiana 46383 United States |
|
Kansas University Medical Center Kansas City Kansas 66160 United States |
|
The Center for the Improvement of Functioning International Wichita Kansas 67219 United States |
|
Complementary Medical Services Mandeville Louisiana 70471 United States |
|
Maine Integrative Wellness Portland Maine 04103 United States |
|
Johns Hopkins Bayview Medical Center Baltimore Maryland 21224 United States |
|
Marino Center for Progressive Health Cambridge Massachusetts 02140 United States |
|
Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine Detroit Michigan 48202 United States |
|
The Preventive Medicine Center Flint Michigan 48503 United States |
|
Born Preventive Health Care Clinic Grand Rapids Michigan 49512 United States |
|
Parchment Family Practice Kalamazoo, Michigan 49004 United States |
|
Berman Center for Outcomes and Clinical Research Minneapolis Minnesota 55404 United States |
|
Mayo Clinic and Foundation Cardiovascular Health Clinic Rochester Minnesota 55905 United States |
|
University of Missouri Hospital and Clinics Columbia Missouri 65201 United States |
|
Brian Dieterle, MD, PhD Hollister Missouri 65673 United States |
|
Preventive Medicine St. Louis Missouri 63146 United States |
|
Deborah Heart and Lung Center Browns Mills New Jersey 08015 United States |
|
Magaziner Center for Wellness Cherry Hill New Jersey 08003 United States |
|
Park Professional Building Roselle Park New Jersey 07204 United States |
|
Stockton Family Practice Stockton New Jersey 08559 United States |
|
Bronx-Lebanon Hospital Center Bronx New York 10457 United States |
|
Heart Care Center East Syracuse New York 13057 United States |
|
The Gables Natural Medicines Center & Day Spa Family Health Services Mayville New York 14757 United States |
|
NYU School of Medicine New York New York 10016 United States |
|
Rhinebeck Health Center Rhinebeck New York 12572 United States |
|
Staten Island Heart Staten Island New York 10305 United States |
|
Schachter Center for Complementary Medicine Suffern New York 10901 United States |
|
Integrative Medical Associates, PLLC Tryon North Carolina 28782 United States |
|
Celebration of Health Center Bluffton Ohio 45817 United States |
|
University Hospitals of Cleveland Cleveland Ohio 44106 United States |
|
The Ohio State University Medical Center Columbus Ohio 43210 United States |
|
Comprehensive Heart Care, Inc. Toledo Ohio 43606 United States |
|
Upper Valley Family Care Troy Ohio 45373 United States |
|
COR Research Oklahoma City Oklahoma 73103 United States |
|
St. Charles Health System Bend Oregon 97701 United States |
|
Center for Environmental Medicine Portland Oregon 97220 United States |
|
Wholistic Health Center Greensburg Pennsylvania 15601 United States |
|
Woodlands Healing Research Center Quakertown Pennsylvania 18951 United States |
|
Main Line Health Heart Center Wynnewood Pennsylvania 19096 United States |
|
Biogenesis Medical Center Landrum South Carolina 29356 United States |
|
Athens Surgery Clinic Athens Tennessee 37303 United States |
|
The Castle Clinic, PLLC Johnson City Tennessee 37601 United States |
|
Chelation Centers of Texas Texas City Texas 77591 United States |
|
Freedom Center for Advanced Medicine Provo Utah 84604 United States |
|
The Cardiovascular Group Fairfax Virginia 22031 United States |
|
Virginia Beach General Hospital Virginia Beach Virginia 23454 United States |
|
Hope Medical Holistic Clinic Vancouver Washington 98663 United States |
|
Care Foundation Inc. Wausau Wisconsin 54401 United States |
|
Waters Preventive Medical Center, LTD Wisconsin Dells Wisconsin 53965 United States |
|
Cline Medical Centre Nanaimo British Columbia V9R 2M9 Canada |
|
The Wellness Centre Port Hawkesbury Nova Scotia V4P 1B5 Canada |
|
Chelation Center of Barrie, Inc. Barrie Ontario L4N9T6 Canada |
|
Anti-Aging & Family Wellness Clinic Madoc Ontario K0K 2K0 Canada |
|
Markham Integrative Medicine Markham Ontario L3P 1Y8 Canada |
|
North Bay Complementary North Bay Ontario P1B 4B8 Canada |
|
Seekers Centre for Integrative Medicine Ottawa Ontario K2E 1B3 Canada |
|
Dr. C. Minielly Smith Falls Ontario K7A 1C3 Canada |
|
Chelation Center of Don Valley Inc. Toronto Ontario M3C3F2 Canada |
|
Jaconello Health Centre Toronto Ontario M4K 3T1 Canada |
|
Chelation and Natural Therapy Toronto Ontario M4W 3T1 Canada |
|
Chelox Toronto Ontario M6H 3M2 Canada |
|
Saskatoon Chelation Centre Saskatoon Saskatchewan S7M 5W1 Canada |
Location Countries
Country
Canada
United States
Verification Date
2013-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Mt. Sinai Medical Center, Miami
Investigator Full Name
Gervasio Lamas, MD
Investigator Title
Chair, Department of Medicine- Chief, Division of Cardiology
Has Expanded Access
No
Condition Browse
Secondary Id
U01HL092607
U01AT001156
Number Of Arms
4
Intervention Browse
Mesh Term
Vitamins
Edetic Acid
Pentetic Acid
Arm Group
Arm Group Label
EDTA + high dose vitamin
Arm Group Type
Active Comparator
Description
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
Arm Group Label
EDTA + high dose vitamin placebo
Arm Group Type
Placebo Comparator
Description
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
Arm Group Label
EDTA placebo + high dose vitamin
Arm Group Type
Placebo Comparator
Description
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Arm Group Label
EDTA placebo + high dose vitamin placebo
Arm Group Type
Placebo Comparator
Description
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
August 22, 2002
Study First Submitted Qc
August 22, 2002
Study First Posted
August 23, 2002
Last Update Submitted
August 30, 2013
Last Update Submitted Qc
August 30, 2013
Last Update Posted
November 5, 2013
Results First Submitted
August 30, 2013
Results First Submitted Qc
August 30, 2013
Results First Posted
November 5, 2013
Disposition First Submitted
May 3, 2013
Disposition First Submitted Qc
May 3, 2013
Disposition First Posted
May 13, 2013
ClinicalTrials.gov processed this data on August 23, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.