Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01826773
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2013-04-04
Brief Title:
CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects
Sponsor:
Fluoropharma Inc
Organization:
Fluoropharma Inc
Study Overview
Official Title:
A Phase II Open-Labeled Study to Evaluate CardioPET as a PET Imaging Agent for Evaluation of Myocardial Perfusion and Fatty Acid Uptake in Subjects With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
The study is designed to evaluate how safe and how well an investigational imaging product CardioPET performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients
Detailed Description:
The open label phase II multi center study objectives are as follows
To evaluate the diagnostic performance of CardioPET in assessing myocardial perfusion as compared to standard Tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for CAD
To evaluate the safety of CardioPET in known or suspected CAD subjects
A secondary objective is to assess fatty acid uptake at rest and following stress
To evaluate the diagnostic performance of CardioPET in assessing myocardial perfusion as compared to standard Tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for CAD
To evaluate the safety of CardioPET in known or suspected CAD subjects
A secondary objective is to assess fatty acid uptake at rest and following stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-002261-36 | EUDRACT_NUMBER | None | None |