title: Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.
abstract: BACKGROUND
  The National Institutes of Health.funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stablecoronary disease patients aged .50 years who were .6 months post.myocardial infarction (2003.2010) to 40 infusions ofa multicomponent EDTA chelation solution or placebo. Chelation reduced the primary composite end point of mortality,recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio, 0.82; 95%confidence interval, 0.69.0.99; P=0.035).
  
  
  RESULTS
  In a randomly selected subset of 911 patients, we prospectively collected a battery of quality-of-life(QOL) instruments at baseline and at 6, 12, and 24 months after randomization. The prespecified primary QOL measures were the Duke Activity Status Index (Table I in the Data Supplement) and the Medical Outcomes Study Short-Form 36 Mental Health Inventory-5. All comparisons were by intention to treat. Baseline clinical and QOL variables were well balanced in the 451 patients randomized to chelation and in the 460 patients randomized to placebo. The Duke Activity Status Index improved in both groups during the first 6 months of therapy, but we found no evidence for a treatment-related difference (mean difference [chelation.placebo] during follow-up, 0.9 [95% confidence interval, .0.7 to 2.6; P=0.27]).There was no statistically significant evidence of a treatment-related difference in the Mental Health Inventory-5 during follow-up (mean difference, 1.0; 95% confidence interval, .0.1 to 2.0; P=0.08). None of the secondary QOL measures showed a consistent treatment-related difference.
  
  
  CONCLUSIONS
  In stable, predominantly asymptomatic coronary disease patients with a history of myocardial infarction,EDTA chelation therapy did not have a detectable effect on QOL during 2 years of follow-up.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov. Unique identifier: NCT00044213.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Clapp-Channing
authors.forename: J David
authors.initials: JD
authors.lastname: Knight
authors.forename: Robin
authors.initials: R
authors.lastname: Boineau
authors.forename: Christine
authors.initials: C
authors.lastname: Goertz
authors.forename: Theodore C
authors.initials: TC
authors.lastname: Rozema
authors.forename: Diane M
authors.initials: DM
authors.lastname: Liu
authors.forename: Richard L
authors.initials: RL
authors.lastname: Nahin
authors.forename: Yves
authors.initials: Y
authors.lastname: Rosenberg
authors.forename: Jeanne
authors.initials: J
authors.lastname: Drisko
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
authors.forename: Gervasio A
authors.initials: GA
authors.lastname: Lamas
mesh_terms: D000328:Adult; D000368:Aged; D065096:Calcium Chelating Agents / Q000008:administration & dosage; D015913:Chelation Therapy / Q000379:methods*; D003324:Coronary Artery Disease / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004492:Edetic Acid / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D065096:Calcium Chelating Agents; D004492:Edetic Acid