NCT00514501

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

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Iodofiltic acid I 123

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-12-01
• First posted: 2007-08-10
• Last updated: 2016-03-31
• Results posted: 2016-01-25

Locations

38 sites across 2 countries: United States, Canada