Trial to Assess Chelation Therapy (TACT) - Full Text View

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 Drug: Placebo infusions	Phase III

MedlinePlus related topics:

Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Trial to Assess Chelation Therapy (TACT)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

All cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1950
Study Start Date:	September 2003
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive 40 infusions of standard chelation solution.	Drug: EDTA chelation therapy Participants will receive 40 infusions of standard chelation solution.
2: Placebo Comparator Participants will receive 40 infusions of placebo.	Drug: Placebo infusions Participants will receive 40 infusions of 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, 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 108 Study Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Study Director:	Gervasio A Lamas, M.D.	University of Miami

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

Responsible Party:	University of Miami School of Medicine ( Gervasio A. Lamas, MD )
Study ID Numbers:	U01 HL092607
First Received:	August 22, 2002
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00044213
Health Authority:	United States: Food and Drug Administration

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 November 19, 2008

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