Trial to Assess Chelation Therapy (TACT)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: EDTA; Dietary supplement: High Dose Vitamin; Dietary supplement: High Dose Vitamin Placebo; Drug: EDTA Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1708
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EDTA + high dose vitamin; Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.	Drug: EDTA; Participants will receive 40 infusions of standard chelation solution.; Dietary supplement: High Dose Vitamin
Placebo Comparator: EDTA + high dose vitamin placebo; Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.	Drug: EDTA; Participants will receive 40 infusions of standard chelation solution.; Dietary supplement: High Dose Vitamin Placebo
Placebo Comparator: EDTA placebo + high dose vitamin; Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.	Dietary supplement: High Dose Vitamin; Drug: EDTA Placebo; Participants will receive 40 infusions of EDTA placebo.
Placebo Comparator: EDTA placebo + high dose vitamin placebo; Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.	Dietary supplement: High Dose Vitamin Placebo; Drug: EDTA Placebo; Participants will receive 40 infusions of EDTA placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.	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.	Measured over a maximum 5-year follow-up period- 55 month median

Collaborators and Investigators

• Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Director: Gervasio A Lamas, M.D., Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.
• Mark 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.
• Lamas 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.
• Escolar 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.
• Lamas 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.
• Lamas 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 22, 2002
• First Submitted That Met QC Criteria: August 22, 2002
• First Posted (Estimate): August 23, 2002

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: August 30, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Vitamins; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: 654; U01HL092607 (U.S. NIH Grant/Contract); U01AT001156 (U.S. NIH Grant/Contract)