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 |
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.
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
We found this trial at
37
sites
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