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Trial to Assess Chelation Therapy (TACT)

This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), September 2007

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00044213
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: EDTA chelation therapy
Phase III

MedlinePlus related topics:   Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:   Trial to Assess Chelation Therapy (TACT)

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   1950
Study Start Date:   September 2003
Estimated Study Completion Date:   July 2009

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, 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.

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria for Participants:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044213

Contacts
Contact: NCCAM Clearinghouse     1-888-644-6226    

Show 163 study locations  Show 163 Study Locations

Sponsors and Collaborators

Investigators
Study Director:     Anthony Lamas, M.D.     Mt. Sinai Medical Center of Florida    
  More Information

View the NIH press release and Q & A regarding the study from here.  This link exits the ClinicalTrials.gov site
 
Sites are being added frequently; click here to view a current list from the NCCAM web site.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   U01 AT001156-01
First Received:   August 22, 2002
Last Updated:   September 25, 2007
ClinicalTrials.gov Identifier:   NCT00044213
Health Authority:   United States: Food and Drug Administration;   United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 08, 2008




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