At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 510 enrolled
Drug / intervention
Iodofiltic acid I 123drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 2 clinical trial evaluating Iodofiltic acid I 123 for Acute Coronary Syndrome. Completed, enrolled 510 participants across 38 sites in 2 countries.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedAug 2007
Primary CompletionJun 2008
Study CompletionDec 2008
TodayJul 2026
First PostedAug 10, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.9 years ago
Interventions
Iodofiltic acid I 123drug