Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514501
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2007-08-08
Brief Title:
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
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
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Zeus-ACS
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None