Phase 2
N=510
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00514501 ↗Enrolled (actual)
510
Serious AEs
5.5%
Results posted
Jan 2016
Primary outcome: Primary: Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) — 75.2; 67.7 % (n/N)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Iodofiltic acid I 123 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) |
75.2; 67.7 | — |
| PRIMARY Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) |
75.2; 59.8 | — |
| PRIMARY Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) |
74.3; 71.6 | — |
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.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT00514501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.