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NCT00514501 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
A Phase 2 study of Acute Coronary Syndrome, sponsored by Molecular Insight Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT00514501: Completed Phase 2 study of Acute Coronary Syndrome, sponsored by Molecular Insight Pharmaceuticals.
NCT00514501 is a Phase 2 study of Acute Coronary Syndrome that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 510 participants, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00514501, a Phase 2 study of Acute Coronary Syndrome, has completed, sponsored by Molecular Insight Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 F
Conditions Studied
Interventions
- DRUG Iodofiltic acid I 123
Study Locations (20)
California
- - Los Angeles
- - Mission Viejo
- - Newport Beach
- - Roseville
Michigan
- - Detroit
- - Royal Oak
- - Troy
Alabama
- - Birmingham
- - Huntsville
Connecticut
- - Hartford
- - New Haven
Illinois
- - Aurora
- - Maywood
Arizona
- - Mesa
Delaware
- - Newark
Florida
- - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00514501 record still lists
NCT00514501 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, below the 2,709-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Iodofiltic acid I 123 is the first listed.
NCT00514501 names 20 study sites across 12 states, led by California, Michigan, Alabama.
Frequently Asked Questions
What is clinical trial NCT00514501 about?
NCT00514501 is a clinical study titled "Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome". 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 ...
What is the current status of trial NCT00514501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 510 participants. The study started on 2007-05. Estimated completion is 2008-12.
What conditions does trial NCT00514501 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT00514501?
The interventions under investigation include: Iodofiltic acid I 123 (DRUG).
Who is sponsoring clinical trial NCT00514501?
This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00514501 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00514501's enrollment target sits among peer trials
510 19th of 40 higher than 22 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Coronary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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