Trial to Assess Chelation Therapy (TACT)

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Edetic Acid; Pentetic Acid; Vitamins

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.