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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:4/21/2016
Start Date:May 2007
End Date:December 2008

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Open-label, Phase 2 Study of the Safety and Efficacy of B-methyl-P-(123I)- Iodophenyl-pentadecanoic Acid (Iodofiltic Acid I 123) For Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (Spect) in Adults With Symptoms Consistent With Acute Coronary Syndrome (ACS).

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.


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
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