Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123 for the detection of myocardial ischemia. Readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. The resulting independent reading of the images will be compared against the truth standard for ACS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Provide written informed consent and are willing to comply with protocol requirements

• Are 40 years of age or older.

• Are being evaluated for possible ACS.

• If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

• <40 years of age.

• Females who are pregnant or lactating.

• History of left ventricular ejection fraction (LVEF)=40%.

• History of MI.

• Acute ST segment elevation on ECG.

• Left bundle branch block on ECG.

• Known history of significant allergy to x-ray contrast media or iodine/iodides.

• Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).

• Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.

• Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.

• Serum creatinine level >2.0 mg per dL.

• Received investigational compound and/or medical device within 30 days of admission into this study.

• Q-wave abnormalities consistent with previous MI