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8110 Gatehouse Road, Falls Church, VA 22042

TACT2

General Information

Age Group

Adult

Status

Active

Protocol Number

152626

Background Information

Trial to Assess Chelation Therapy in patients with a history of diabetes and myocardial infarction.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Christopher deFilippi MD

Eligibility Information

  • ≥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.

Ineligibility Information

  • 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.