Trial to Assess Chelation Therapy (TACT)

Coronary Artery Disease Clinical Trial

Official title:

Trial to Assess Chelation Therapy (TACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044213
• Other study ID #: 654
• Secondary ID: U01HL092607U01AT
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2002
• Last updated: August 30, 2013
• Start date: September 2003
• Est. completion date: August 2012

Study information

• Verified date: August 2013
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1708
• Est. completion date: August 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• EDTA
Participants will receive 40 infusions of standard chelation solution.
• EDTA Placebo
Participants will receive 40 infusions of EDTA placebo.

Dietary Supplement:
• High Dose Vitamin

• High Dose Vitamin Placebo

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami	National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   View the NIH press release and Q & A regarding the study from here.