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History of Changes for Study: NCT00044213
Trial to Assess Chelation Therapy (TACT)
Latest version (submitted August 30, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 August 2, 2005 Study Description, Study Status, Contacts/Locations and Eligibility
3 August 10, 2005 Contacts/Locations and Study Status
4 August 12, 2005 Contacts/Locations and Study Status
5 September 11, 2005 Study Status and Contacts/Locations
6 December 30, 2005 Contacts/Locations and Study Status
7 January 30, 2006 Contacts/Locations and Study Status
8 February 24, 2006 Study Status and Contacts/Locations
9 March 7, 2006 Contacts/Locations and Study Status
10 April 20, 2006 Contacts/Locations and Study Status
11 May 31, 2006 Study Status and Contacts/Locations
12 June 6, 2006 Contacts/Locations and Study Status
13 July 7, 2006 Study Status and Contacts/Locations
14 July 24, 2006 Contacts/Locations and Study Status
15 August 10, 2006 Study Status, Contacts/Locations and Study Design
16 August 17, 2006 Study Identification and Study Status
17 September 12, 2006 Study Status and Contacts/Locations
18 October 16, 2006 Study Status and Contacts/Locations
19 March 20, 2007 Study Status, Contacts/Locations and Oversight
20 September 25, 2007 Contacts/Locations, Study Status and Study Design
21 October 7, 2008 Contacts/Locations, Sponsor/Collaborators, Study Status, Arms and Interventions, Study Identification, Study Design and Outcome Measures
22 April 29, 2009 Contacts/Locations, Study Status and Sponsor/Collaborators
23 May 28, 2009 Study Identification and Study Status
24 July 14, 2009 Study Status
25 August 24, 2009 Contacts/Locations, Study Status and Study Design
26 July 6, 2010 Recruitment Status, Study Status and Contacts/Locations
27 July 26, 2010 Contacts/Locations and Study Status
28 May 10, 2012 Study Status, Sponsor/Collaborators and Study Design
29 October 4, 2012 Study Status, Outcome Measures and Study Description
30 October 9, 2012 Study Status
31 February 12, 2013 Sponsor/Collaborators, Study Identification and Study Status
32 April 23, 2013 Recruitment Status and Study Status
33 May 3, 2013 Study Status, Arms and Interventions and Study Design
34 August 30, 2013 Arms and Interventions, Study Status, Outcome Measures, More Information, Adverse Events, Baseline Characteristics, Participant Flow and Eligibility
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Study NCT00044213
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1U01AT001156-01
Brief Title: Trial to Assess Chelation Therapy (TACT)
Official Title: Trial to Assess Chelation Therapy (TACT)
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2005
Overall Status: Recruiting
Study Start: March 2003
Primary Completion:
Study Completion:
First Submitted: August 22, 2002
First Submitted that
Met QC Criteria:
August 22, 2002
First Posted: August 23, 2002 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
Responsible Party:
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine the safety and effectiveness of EDTA chelation therapy in individuals with coronary artery disease.
Detailed Description:

This study is a comparing 40 infusions of the standard chelation solution versus 40 infusions of placebo. Chelation therapy, as practiced in the community, also includes the use of high dose antioxidant vitamin and mineral supplements. Thus, any clinical benefit of chelation therapy may be due either to the effect of EDTA chelation, or high dose supplements, or both. Therefore, we are conducting a 2X2 factorial design to independently test the effects of a high-dose supplementation, versus a low dose regimen to simply replace chelation-related losses. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure.

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.

Open or close this module Conditions
Conditions: Coronary Artery Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 2372
Open or close this module Arms and Interventions
Intervention Details:
Drug: EDTA chelation therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria for Participants:

  • 50 years of age or older
  • Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

  • 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
  • Diagnoses of additional medical conditions that could otherwise limit patient survival
Open or close this module Contacts/Locations
Central Contact Person: NCCAM Clearinghouse
Telephone: 1-888-644-6226
Central Contact Backup: Alyssa Cotler
Telephone: 301-451-3851
Locations: United States, Alabama
Wellness Center of Anniston
[Recruiting]
Anniston, Alabama, United States, 36201
United States, Alaska
Alaska Cardiovascular Research Foundation
[Recruiting]
Anchorage, Alaska, United States, 99508
United States, Arizona
Cardiac Solutions
[Recruiting]
Peoria, Arizona, United States, 85381
Coyote Healing Center
[Recruiting]
Tucson, Arizona, United States, 85715
United States, Arkansas
Central Arkansas Veterans Healthcare System
[Recruiting]
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences
[Recruiting]
Little Rock, Arkansas, United States, 72205
Arkansas Center for Physical Medicine and Rehabilitation
[Recruiting]
North Little Rock, Arkansas, United States, 72114
United States, California
Patrick A. Golden
[Recruiting]
Fresno, California, United States, 93720
Scripps Center for Integrative Medicine
[Recruiting]
La Jolla, California, United States, 92037
Casdorph Clinic
[Recruiting]
Long Beach, California, United States, 90804
Phoenix Wellness Group
[Recruiting]
Napa, California, United States, 94558
Gordon Medical Associates
[Recruiting]
Santa Rosa, California, United States, 95404
United States, Colorado
Aurora Denver Cardiology Associates
[Recruiting]
Denver, Colorado, United States, 80218
Frontier Medical Institute
[Recruiting]
Denver, Colorado, United States, 80401
United States, Florida
Florida Cardiovascular Group - Research
[Recruiting]
Atlantis, Florida, United States, 33462
Integrated Healing Arts
[Recruiting]
Bradenton, Florida, United States, 34210
Wellness Works
[Recruiting]
Brandon, Florida, United States, 33510
Alternative Health Center
[Active, not recruiting]
Englewood, Florida, United States, 34224
Southwest Florida Heart Group
[Recruiting]
Fort Myers, Florida, United States, 33919
White-Wilson Medical Center
[Recruiting]
Fort Walton Beach, Florida, United States, 32547
Mueller Institute for Functional Medicine and Research
[Recruiting]
Lake Mary, Florida, United States, 32746
Innovative Research of West Florida
[Recruiting]
Largo, Florida, United States, 33770
Tru Med
[Recruiting]
Melbourne, Florida, United States, 32901
Ana M. Lamas, M.D.
[Active, not recruiting]
Miami, Florida, United States, 33145
Baptist Cardiac & Vascular Institute
[Recruiting]
Miami, Florida, United States, 33176
Caring Cardiology
[Recruiting]
Miami Beach, Florida, United States, 33140
Miami Heart Research Institute
[Active, not recruiting]
Miami Beach, Florida, United States, 33140
Mount Sinai Medical Center
[Recruiting]
Miami Beach, Florida, United States, 33140
Pain and Healing Center
[Recruiting]
Miami Springs, Florida, United States, 33166
Tri-Health Alternative Medical Center
[Recruiting]
Mt. Dora, Florida, United States, 32757
Cardiology Consultants
[Not yet recruiting]
Pensacola, Florida, United States, 32501
Heart and Vascular Center for Research, Inc.
[Recruiting]
Sarasota, Florida, United States, 34239
The Broward Heart Group, P.A.
[Recruiting]
Tamarac, Florida, United States, 33321
Florida Cardiovascular Institute
[Recruiting]
Tampa, Florida, United States, 33609
Tequesta Family Practice
[Recruiting]
Tequesta, Florida, United States, 33469
United States, Georgia
International Medical Clinic
[Not yet recruiting]
Doraville, Georgia, United States, 30340
Full Circle Medical Center
[Recruiting]
Fort Oglethorpe, Georgia, United States, 30742
Riverside Family Medical
[Recruiting]
Lawrenceville, Georgia, United States, 30043
United States, Illinois
Evanston Northwestern Healthcare
[Active, not recruiting]
Evanston, Illinois, United States, 60201
United States, Indiana
Crossroads Healing Arts LLC
[Recruiting]
Goshen, Indiana, United States, 46528
Center for Health Enrichment
[Active, not recruiting]
Plymouth, Indiana, United States, 46563
Northwest Indiana Cardiovascular Physicians Inc.
[Recruiting]
Valparaiso, Indiana, United States, 46383
United States, Kansas
Kansas University Medical Center
[Recruiting]
Kansas City, Kansas, United States, 66160
United States, Louisiana
Family/ Complimentary Medicine
[Recruiting]
Baton Rouge, Louisiana, United States, 70806
Wellness and Longevity Center of Louisiana
[Recruiting]
Lafayette, Louisiana, United States, 70508
Complementary Medical Services
[Recruiting]
Mandeville, Louisiana, United States, 70471
Complementary Medical Services
[Recruiting]
Metairie, Louisiana, United States, 70002
Crescent City Clinical Services
[Active, not recruiting]
New Orleans, Louisiana, United States, 70115
Northeast LA Anti-Aging and Wellness Center
[Recruiting]
West Monroe, Louisiana, United States, 71291
United States, Maine
Androscoggin Cardiology Associates
[Recruiting]
Auburn, Maine, United States, 04210
United States, Maryland
Johns Hopkins Bayview Medical Center
[Recruiting]
Baltimore, Maryland, United States, 21224
Total Sensory Wellness Center
[Active, not recruiting]
Waldorf, Maryland, United States, 20602
United States, Massachusetts
Marino Center for Progressive Health
[Not yet recruiting]
Cambridge, Massachusetts, United States, 02140
Baystate Medical Center
[Recruiting]
Springfield, Massachusetts, United States, 01199
United States, Michigan
The Preventive Medicine Center
[Recruiting]
Flint, Michigan, United States, 48503
Born Preventive Health Care Clinic
[Recruiting]
Grand Rapids, Michigan, United States, 49512
Parchment Family Practice
[Recruiting]
Kalamazoo, Michigan, United States, 49004
Family Health Care Center
[Active, not recruiting]
Royal Oak, Michigan, United States, 48073
United States, Missouri
University of Missouri Hospital and Clinics
[Recruiting]
Columbia, Missouri, United States, 65201
St. Louis Heart and Vascular
[Active, not recruiting]
St. Louis, Missouri, United States, 63110
Preventive Medicine
[Recruiting]
St. Louis, Missouri, United States, 63146
United States, Nebraska
West Holt Medical Clinic
[Recruiting]
Atkinson, Nebraska, United States, 68713
The Camelot Foundation
[Active, not recruiting]
Omaha, Nebraska, United States, 68114
United States, New Jersey
Deborah Heart and Lung Center
[Recruiting]
Browns Mills, New Jersey, United States, 08015
Magaziner Center for Wellness
[Recruiting]
Cherry Hill, New Jersey, United States, 08003
Integrative family Medicine Our lady of Lourdes Medical Center
[Recruiting]
Collingswood, New Jersey, United States, 08108
The Institute of Integrative Medicine
[Recruiting]
Denville, New Jersey, United States, 07834
Edison Medical Nutrition Center
[Recruiting]
Edison, New Jersey, United States, 08837
Yulius Poplyansky, M.D.
[Recruiting]
Roselle Park, New Jersey, United States, 07204
Longevity Medical, PA
[Recruiting]
South Amboy, New Jersey, United States, 08879
Stockton Family Practice
[Recruiting]
Stockton, New Jersey, United States, 08559
Mid-Atlantic Clinical Studies
[Recruiting]
West Caldwell, New Jersey, United States, 07006
David Strassberg, M.D.
[Active, not recruiting]
Woodbridge, New Jersey, United States, 07095
United States, New York
Bronx-Lebanon Hospital Center
[Recruiting]
Bronx, New York, United States, 10457
Heart Care Center
[Recruiting]
East Syracuse, New York, United States, 13057
New York VA
[Recruiting]
New York, New York, United States, 10010
NYU School of Medicine
[Recruiting]
New York, New York, United States, 10016
Hudson Valley Heart Center
[Recruiting]
Poughkeepsie, New York, United States, 12601
Rhinebeck Health Center
[Recruiting]
Rhinebeck, New York, United States, 12572
Schachter Center for Complementary Medicine
[Recruiting]
Suffern, New York, United States, 10901
United States, North Carolina
Mark O'Neil Speight, M.D.
[Recruiting]
Charlotte, North Carolina, United States, 28202
Advanced Concepts in Medicine
[Active, not recruiting]
Cornelius, North Carolina, United States, 28031
Duke University Medical Center
[Active, not recruiting]
Durham, North Carolina, United States, 27708
Boice Willis Clinic
[Recruiting]
Rocky Mount, North Carolina, United States, 27804
Interative Medical Associates, PLLC
[Recruiting]
Tryon, North Carolina, United States, 28782
United States, Ohio
Celebration of Health Center
[Recruiting]
Bluffton, Ohio, United States, 45817
Lake Cable Medical Center
[Recruiting]
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
[Recruiting]
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
[Recruiting]
Columbus, Ohio, United States, 43210
Arnold Good, M.D.
[Active, not recruiting]
Columbus, Ohio, United States, 43215
Advanced Family Medicine
[Recruiting]
Grove City, Ohio, United States, 43123
United States, Oklahoma
Jenks Health Team
[Recruiting]
Jenks, Oklahoma, United States, 74037
COR Research
[Recruiting]
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Chris Hatlestad, MD, PC
[Recruiting]
Bend, Oregon, United States, 97701
United States, Pennsylvania
Wholistic Health Center
[Recruiting]
Greensburg, Pennsylvania, United States, 15601
Haverford Wellness Center
[Recruiting]
Haverford, Pennsylvania, United States, 19083
Main Line Health Heart Center
[Recruiting]
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Biogenesis Medical Center
[Recruiting]
Landrum, South Carolina, United States, 29356
Advantage Health Center, LLC
[Recruiting]
Myrtle Beach, South Carolina, United States, 29588
United States, Tennessee
1005 DR D.B. Todd Boulevard
[Active, not recruiting]
Nashville, Tennessee, United States, 37208
United States, Texas
Lake Travis Medical, PA
[Recruiting]
Austin, Texas, United States, 78734
Longevity Center of Houston
[Recruiting]
Houston, Texas, United States, 77027
Grace Medical Association
[Recruiting]
Lewisville, Texas, United States, 75057
Tyler Total Wellness Center, PA
[Recruiting]
Tyler, Texas, United States, 75703
United States, Utah
Freedom Center for Advanced Medicine
[Recruiting]
Provo, Utah, United States, 84604
United States, Virginia
The Cardiovascular Group
[Recruiting]
Fairfax, Virginia, United States, 22031
Virginia Beach General Hospital
[Recruiting]
Virginia Beach, Virginia, United States, 23454
United States, Washington
Hope Medical Holistic Clinic
[Recruiting]
Vancouver, Washington, United States, 98663
United States, Wisconsin
Bircher Chiropractic and Wellness Center
[Recruiting]
Eau Claire, Wisconsin, United States, 54701
Milwaukee Cardiovascular Research Foundation
[Recruiting]
Milwaukee, Wisconsin, United States, 53215
Care Foundation Inc.
[Recruiting]
Wausau, Wisconsin, United States, 54401
Waters Preventive Medical Center, LTD
[Recruiting]
Wisconsin Dells, Wisconsin, United States, 53965
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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