Phase
Condition
Coronary Artery Disease
Blood Clots
Congestive Heart Failure
Treatment
disodium EDTA
Oral Multi Vitamins/Minerals (OMVM)
Placebo Oral Multi Vitamins/Minerals (OMVM)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: ≥ 50 years
History of diabetes, defined as medical record evidence or patient report ofcurrently using insulin or oral hypoglycemic agents, or with a history of fastingblood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% orhigher.
History of myocardial infarction based on the Universal Definition of MI.
When information about the MI hospitalization is available, all MI types exceptType 2 qualify for study entry.
When information about the MI hospitalization is not available, a wall motionabnormality on imaging or a perfusion defect on scan that corresponds to acoronary distribution, whether or not accompanied by pathological Q waves inthe appropriate distribution, will qualify the patient for study entry. Thiscriterion requires a call to the CCC for case review.
Exclusion
Exclusion Criteria:
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 chelationsolution, including heparin. Site personnel are to call the CCC to discuss heparinallergy.
Coronary or peripheral arterial revascularization procedure performed within thelast 6 months.
Planned revascularization procedure in the 6 months following enrollment.
Heart failure hospitalization within 6 months prior to enrollment or in clinicalheart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea +rales >basilar, and additional signs of fluid overload). Such patients may betreated with diuretics and enrolled when stable.
Poor or no venous access in the upper extremities.
a. Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; ifonly 1 infusion took place, patient cannot be enrolled for at least 12 months aftersaid infusion. b. Oral chelation therapy with an approved oral chelating agent within 2 years.
Prior participation in TACT.
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-melanomaskin 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 adhereto the protocol.
Women of child-bearing potential including those with plans for post-menopausal invitro fertilization or other reproductive technology.
Study Design
Study Description
Connect with a study center
Mount Sinai Medical Center
Miami Beach, Florida 33132
United StatesSite Not Available
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