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

Completed · Phase 2

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT00514501

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

510

Starts

2007-05-01

Expected to finish

2008-12-01

Last updated by the study team

2016-03-31

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• <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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Newport Beach, California, United States
• Study site — Roseville, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Jacksonville, Florida, United States
• Study site — Aurora, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — Bethesda, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Manchester, New Hampshire, United States
• Study site — Albany, New York, United States
• Study site — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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