Clinical Trial: Efficacy and Safety of Ad5FGF-4 for Myocardial Ischemia in Patients With Stable Angina Due to Coronary Artery Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Controlled, Parallel Group, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Ad5FGF-4 Using SPECT Myocardial Perfusion Imaging in Patients With Stab
Brief Summary: The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.
Detailed Summary:
Sponsor: Cardium Therapeutics
Current Primary Outcome: Change in reversible perfusion defect size (RPDS) as measured by adenosine triphosphate (ATP) single-photon emission computed tomography with technetium-99m sestamibi (SPECT) [ Time Frame: Baseline and Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in angina frequency and nitroglycerin use [ Time Frame: Baseline and Week 8 ]
- Change in quality of life using the Seattle Angina Questionnaire [ Time Frame: Baseline and Week 8 ]
- Change in patient functional class using CCS anginal classification [ Time Frame: Baseline and Week 8 ]
- Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing [ Time Frame: Through Week 8 ]
- Long-term safety of Ad5FGF-4 as assessed by serious adverse events [ Time Frame: Through Month 12 ]
Original Secondary Outcome: Same as current
Information By: Cardium Therapeutics
Dates:
Date Received: February 29, 2012
Date Started: March 2012
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016
