MU Logo Department of Internal Medicine at MUMu Health Care

TACT

PI:                    Dr. Greg Flaker
Coordinator:    Sharon Clasby

The purpose of this study is to compare the effects (good and bad) of Chelation Therapy for patients who have survived a heart attack.  The TACT study will test chelation solution against a placebo containing a salt-water solution and high-dose vitamins and minerals taken by mouth against a low-dose preparation.

Inclusion:           

  1. Men or women age 50 years or older (women must be post-menopausal).
  2. Documented myocardial infarction (MI) over 6 weeks prior to evaluation.  The criteria for MI will be based on the European Society of Cardiology/European Society of Cardiology (ESC/ACC) definition as follows.  Either of the following criteria (A or B):
    1. Typically rise and gradual fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
      1. Ischemic systems
      2. Development of pathologic Q waves on the electrocardiogram (ECG)
      3. ECG changes indicative of ischemia (ST-segment elevation or depression)
    2. Imaging evidence of myocardial scar, coronary angiographic evidence of epicardial coronary disease in the same distribution.  A prior MI may be diagnosed in patients with angiographically defined coronary artery disease (a luminal narrowing greater than 50% of a major epicardial coronary artery) and imaging evidence of myocardial scar including a non-reversible perfusion defect on myocardial radionuclide perfusion imaging or severe wall motion abnormality on contrast angiography, radionuclide angiography, or echocardiography.

Exclusion:

  1. Prior chelation therapy within 5 years of proposed randomization date.
  2. History of allergic reactions to any of the components of the chelation solution or the vitamins and minerals.
  3. Planned revascularization.
  4. Symptomatic heart failure at proposed time of enrollment
  5. Clinically evident heart failure, visible symptomatic volume overload, in the opinion of the treating physician.
  6. Hospitalization for heart failure within 6 months.
  7. Stage II hypertension, defined in the JNC6 guidelines as a blood pressure greater than 160/100.  If blood pressure greater than or equal to 160/100, then the patient may be treated and reevaluated for enrollment at a future date.
  8. No venous access in the upper extremities.
  9. Baseline serum creatinine greater than 2.0 mg/dl.
  10. Baseline platelet count less than 100,000/mm.
  11. History of cigarette smoking within the last 3 months.
  12. History of liver disease.
  13. ALT or AST greater than 2.0 times the upper limit of normal.
  14. Disease of copper (Wilson’s Disease), iron (hemochromatosis, iron deficiency), or calcium (less than 8.0 mg/dl) metabolism.
  15. Inability to tolerate the weekly fluid load (500 cc of normal saline).
  16. Any condition or circumstance such as chronic non-compliance or an itinerant lifestyle that will affect compliance with the study interventions.
  17. Any severe, non-coronary medical condition likely to affect patient survival within 4 years.
  18. Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization.

 

Action:

  1. Determine if patient fits major study criteria.
  2. Determine if patient is interested in joining a clinical trial.
  3. Call Sharon Clasby (beeper 815-1268) and/or on-call research nurse (on-call beeper 499-8084) or Dr. Flaker to complete screening of patient.

 

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Last Revised: 02/13/2006