Human Recombinant Fibroblast Growth Factor-1 (FGF-1), for the Treatment of Subjects With Severe Coronary Heart Disease, a Placebo Controlled, Double-blind, Dose-varying Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Disease
- Sponsor
- CardioVascular BioTherapeutics, Inc.
- Enrollment
- 150
- Primary Endpoint
- Change in cardiac perfusion as measured by cMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography
- Last Updated
- 6 years ago
Overview
Brief Summary
Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.
Detailed Description
Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in cardiac perfusion as measured by cMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography
Time Frame: 1 year
Change in cardiac perfusion as measured by cMRI scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography
Change in CCS angina score
Time Frame: baseline to 12 weeks, followed up to one year
Change in CCS angina score
Secondary Outcomes
- Exercise treadmill test: time (or change in time) to onset of at least 1 mm additional horizontal or downsloping ST-segment depression, or time to ETT in the absence of at least 1 mm additional ST-segment depression due to pain (angina)(1 year)