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).
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 510
- Primary Endpoint
- Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Iodofiltic Acid I 123
Intervention: Iodofiltic acid I 123 (Drug)
Outcomes
Primary Outcomes
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
Time Frame: Day 30
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.
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
Time Frame: Day 30
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.
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
Time Frame: Day 30
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.
Secondary Outcomes
No secondary outcomes reported