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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Iodofiltic acid I 123


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodofiltic Acid I 123<br> | Drug: Iodofiltic acid I 123<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) | Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. | Day 30 | 
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) | Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. | Day 30 | 
| Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) | Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. | Day 30 |