Trial to Assess Chelation Therapy (TACT)
3 other identifiers
interventional
1,708
2 countries
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Sep 2003
Longer than P75 for phase_3 coronary-artery-disease
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2002
CompletedFirst Posted
Study publicly available on registry
August 23, 2002
CompletedStudy Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
November 5, 2013
CompletedNovember 5, 2013
August 1, 2013
8.1 years
August 22, 2002
August 30, 2013
August 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
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.
Measured over a maximum 5-year follow-up period- 55 month median
Secondary Outcomes (1)
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
Study Arms (4)
EDTA + high dose vitamin
ACTIVE COMPARATORParticipants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
EDTA + high dose vitamin placebo
PLACEBO COMPARATORParticipants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
EDTA placebo + high dose vitamin
PLACEBO COMPARATORParticipants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
EDTA placebo + high dose vitamin placebo
PLACEBO COMPARATORParticipants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Interventions
Participants will receive 40 infusions of standard chelation solution.
Participants will receive 40 infusions of EDTA placebo.
Eligibility Criteria
You may qualify if:
- Heart attack at least 6 weeks prior to study start
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
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
Hyperbaric Medicine Inc.
Fort Walton Beach, Florida, 32547, United States
White-Wilson Medical Center
Fort Walton Beach, Florida, 32547, United States
Tru Med
Melbourne, Florida, 32901, United States
Baptist Cardiac & Vascular Institute
Miami, Florida, 33176, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, 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
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
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, 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
Related Publications (6)
Escolar E, Ujueta F, Kim H, Mark DB, Boineau R, Nahin RL, Goertz C, Lee KL, Anstrom KJ, Lamas GA. Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2020 Aug;34(8):107616. doi: 10.1016/j.jdiacomp.2020.107616. Epub 2020 May 7.
PMID: 32446881DERIVEDMark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. doi: 10.1161/CIRCOUTCOMES.114.000977.
PMID: 24987051DERIVEDLamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004.
PMID: 24490264DERIVEDEscolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
PMID: 24254885DERIVEDLamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
PMID: 23532240DERIVEDLamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
PMID: 22172430DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gervasio A. Lamas, M.D.
- Organization
- Mount Sinai Medical Center
Study Officials
- STUDY DIRECTOR
Gervasio A Lamas, M.D.
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Medicine- Chief, Division of Cardiology
Study Record Dates
First Submitted
August 22, 2002
First Posted
August 23, 2002
Study Start
September 1, 2003
Primary Completion
October 1, 2011
Study Completion
August 1, 2012
Last Updated
November 5, 2013
Results First Posted
November 5, 2013
Record last verified: 2013-08