Trial to Assess Chelation Therapy in patients with a history of diabetes and myocardial infarction.
Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042
Christopher deFilippi MD
- ≥50 yo
- History of diabetes
- History of myocardial infarction
- When information about the MI hospitalization is available; all MI types except Type 2 qualify for study entry.
- When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.
- Baseline serum creatinine >2.0 mg/dL.
- HbA1C >11%.
- Myocardial infarction within 6 weeks of randomization.
- History of allergic reactions to EDTA or any other components of the chelation solution, including heparin.
- Coronary or peripheral arterial revascularization procedure performed within the last 6 months.
- Planned revascularization procedure in the 6 months following enrollment.
- Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales >basilar, and additional signs of fluid overload). Such patients may be treated with diuretics and enrolled when stable.
- Poor or no venous access in the upper extremities.
- Prior intravenous chelation therapy within 5 years or oral chelation within 2 years of thetime of proposed randomization.
- Prior participation in TACT1.
- Baseline platelet count <100,000.
- History of cigarette smoking within the last 3 months.
- ALT or AST > 2.0 times the upper limit of normal.
- Wilson’s disease, hemochromatosis, or parathyroid disease.
- Any medical condition including a current diagnosis of cancer (except non-melanoma skin cancer) that will limit patient survival over the duration of the trial.
- Any factor that suggests that the potential participant will not be able to adhere to the protocol.
- Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.