Clinical trial NCT00044213: Trial to Assess Chelation Therapy (TACT)
Official title: Trial to Assess Chelation Therapy (TACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2002-08-23
Enrollment: 1708
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
timeFrame: Measured over a maximum 5-year follow-up period- 55 month median
Secondary outcomes:
measure: A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
timeFrame: Measured over a maximum 5-year follow-up period- 55 month median
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Danville
country: United States
facility: Mt Holistic Health Center
state: California
city: Fresno
country: United States
facility: Patrick A. Golden
state: California
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
city: Napa
country: United States
facility: Phoenix Wellness Group
state: California
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Bradenton
country: United States
facility: The Blend Institute
state: Florida
city: Brandon
country: United States
facility: Wellness Works
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Fort Walton Beach
country: United States
facility: White-Wilson Medical Center
state: Florida
city: Ft. Walton Beach
country: United States
facility: Hyperbaric Medicine Inc.
state: Florida
city: Melbourne
country: United States
facility: Tru Med
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Mt. Dora
country: United States
facility: Tri-Health Alternative Medical Center
state: Florida
city: Sarasota
country: United States
facility: Heart and Vascular Center for Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Florida Cardiovascular Institute
state: Florida
city: The Villages
country: United States
facility: Life Family Practice Center for Complementary and Alternative Medicine
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A. Clinical Research Division
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Fort Oglethorpe
country: United States
facility: Full Circle Medical Center
state: Georgia
city: Goshen,
country: United States
facility: Crossroads Healing Arts LLC
state: Indiana
city: Seymour
country: United States
facility: Integrative Medical Center at Schneck Medical Center
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Cardiovascular Physicians Inc.
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Wichita
country: United States
facility: The Center for the Improvement of Functioning International
state: Kansas
city: Mandeville
country: United States
facility: Complementary Medical Services
state: Louisiana
city: Portland
country: United States
facility: Maine Integrative Wellness
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Cambridge
country: United States
facility: Marino Center for Progressive Health
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System Preventative Cardiology Clay Ford Center for Athletic Medicine
state: Michigan
city: Flint
country: United States
facility: The Preventive Medicine Center
state: Michigan
city: Grand Rapids
country: United States
facility: Born Preventive Health Care Clinic
state: Michigan
city: Kalamazoo,
country: United States
facility: Parchment Family Practice
state: Michigan
city: Minneapolis
country: United States
facility: Berman Center for Outcomes and Clinical Research
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic and Foundation Cardiovascular Health Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics
state: Missouri
city: Hollister
country: United States
facility: Brian Dieterle, MD, PhD
state: Missouri
city: St. Louis
country: United States
facility: Preventive Medicine
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Magaziner Center for Wellness
state: New Jersey
city: Roselle Park
country: United States
facility: Park Professional Building
state: New Jersey
city: Stockton
country: United States
facility: Stockton Family Practice
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: East Syracuse
country: United States
facility: Heart Care Center
state: New York
city: Mayville
country: United States
facility: The Gables Natural Medicines Center & Day Spa Family Health Services
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Rhinebeck
country: United States
facility: Rhinebeck Health Center
state: New York
city: Staten Island
country: United States
facility: Staten Island Heart
state: New York
city: Suffern
country: United States
facility: Schachter Center for Complementary Medicine
state: New York
city: Tryon
country: United States
facility: Integrative Medical Associates, PLLC
state: North Carolina
city: Bluffton
country: United States
facility: Celebration of Health Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: Comprehensive Heart Care, Inc.
state: Ohio
city: Troy
country: United States
facility: Upper Valley Family Care
state: Ohio
city: Oklahoma City
country: United States
facility: COR Research
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Health System
state: Oregon
city: Portland
country: United States
facility: Center for Environmental Medicine
state: Oregon
city: Greensburg
country: United States
facility: Wholistic Health Center
state: Pennsylvania
city: Quakertown
country: United States
facility: Woodlands Healing Research Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
city: Landrum
country: United States
facility: Biogenesis Medical Center
state: South Carolina
city: Athens
country: United States
facility: Athens Surgery Clinic
state: Tennessee
city: Johnson City
country: United States
facility: The Castle Clinic, PLLC
state: Tennessee
city: Texas City
country: United States
facility: Chelation Centers of Texas
state: Texas
city: Provo
country: United States
facility: Freedom Center for Advanced Medicine
state: Utah
city: Fairfax
country: United States
facility: The Cardiovascular Group
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach General Hospital
state: Virginia
city: Vancouver
country: United States
facility: Hope Medical Holistic Clinic
state: Washington
city: Wausau
country: United States
facility: Care Foundation Inc.
state: Wisconsin
city: Wisconsin Dells
country: United States
facility: Waters Preventive Medical Center, LTD
state: Wisconsin
city: Nanaimo
country: Canada
facility: Cline Medical Centre
state: British Columbia
city: Port Hawkesbury
country: Canada
facility: The Wellness Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Chelation Center of Barrie, Inc.
state: Ontario
city: Madoc
country: Canada
facility: Anti-Aging & Family Wellness Clinic
state: Ontario
city: Markham
country: Canada
facility: Markham Integrative Medicine
state: Ontario
city: North Bay
country: Canada
facility: North Bay Complementary
state: Ontario
city: Ottawa
country: Canada
facility: Seekers Centre for Integrative Medicine
state: Ontario
city: Smith Falls
country: Canada
facility: Dr. C. Minielly
state: Ontario
city: Toronto
country: Canada
facility: Chelation Center of Don Valley Inc.
state: Ontario
city: Toronto
country: Canada
facility: Jaconello Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Chelation and Natural Therapy
state: Ontario
city: Toronto
country: Canada
facility: Chelox
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Chelation Centre
state: Saskatchewan
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Gervasio A Lamas, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.