Clinical Trial: Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Female Patients With Stable Angina Pectoris

Brief Summary: The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Detailed Summary:
Sponsor: Cardium Therapeutics

Current Primary Outcome: Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT [ Time Frame: Month 6 ]

Original Primary Outcome: Change from baseline to Month 6 in time to onset of ECG changes diagnostic of myocardial ischemia during ETT

Current Secondary Outcome:

  • Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint) [ Time Frame: Month 6 ]
  • Change in total exercise treadmill time [ Time Frame: Months 3, 6 and 12 ]
  • Change in time to onset ECG changes diagnostic myocardial ischemia during ETT [ Time Frame: Months 3 and 12 ]
  • Change in time to onset of angina during ETT [ Time Frame: Months 3, 6 and 12 ]
  • Change in angina frequency and nitroglycerin [ Time Frame: Months 3 and 6 ]
  • Change in patient functional status using CCS angina class [ Time Frame: Months 3, 6 and 12 ]
  • Change in rest and stress left ventricular ejection fraction assessed using gated SPECT [ Time Frame: Month 6 ]
  • Change in quality of life using the Seattle Angina Questionnaire [ Time Frame: Months 6 and 12 ]
  • Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing [ Time Frame: Through month 12 ]
  • Long-term safety of Ad5FGF-4 as assessed by clinically important events [ Time Frame: Through month 60 ]


Original Secondary Outcome:

  • Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT) from baseline to Month 6 (principal secondary endpoint)
  • Change in total exercise treadmill time from baseline to Months 3, 6 and 12
  • Change in time to onset ECG changes diagnostic myocardial ischemia during ETT from baseline to Month 3 and 12
  • Change in time to onset of angina during ETT from baseline to Months 3, 6 and 12
  • Change in angina frequency and nitroglycerin use from baseline to Months 3 and 6
  • Change in patient functional status using CCS angina class at Months 3, 6 and 12
  • Change in rest and stress left ventricular ejection fraction from baseline to Month 6 assessed using gated SPECT
  • Change in quality of life using the Seattle Angina Questionnaire at Months 6 and 12
  • Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing through Month 12
  • Long-term safety of Ad5FGF-4 as assessed by clinically important events occurring through Month 60


Information By: Cardium Therapeutics

Dates:
Date Received: February 21, 2007
Date Started: May 2007
Date Completion:
Last Updated: February 11, 2013
Last Verified: November 2008