Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (Zeus-ACS)

Molecular Insight Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Acute Coronary Syndrome

Treatments

Drug: Iodofiltic acid I 123

Study type

Interventional

Funder types

Industry

Identifiers

NCT00514501

MIP-BP23

Details and patient eligibility

About

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.

Enrollment

510 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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