Clinical Trial: Efficacy of Topical Capsaicin Cream for Stable Angina

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)

Brief Summary: The purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.

Detailed Summary: Patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ECG for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and hemodynamic responses.
Sponsor: Neal Weintraub

Current Primary Outcome:

  • Symptom-limited Exercise Duration as an Indicator of Exercise Capacity [ Time Frame: Application was 45 minutes prior to exercise ]
    Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
  • Time-to-onset of 1mm ST Segment Depression [ Time Frame: Application was 45 minutes prior to exercise ]
    Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
  • Time-to-onset of Angina or Angina Equivalent Symptoms [ Time Frame: Application was 45 minutes prior to exercise ]
    Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
  • Maximal ST Depression [ Time Frame: Application was 45 minutes prior to exercise ]
    Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
  • Maximal Estimated Workload (in METS) [ Time Frame: Application was 45 minutes prior to exercise ]
    Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
  • Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2) [ Time Frame: Phase 2 was not done. ]
    Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
  • Severity of Angina Was Measured. [ Time Frame: Applicatio

    Original Primary Outcome:

    • Symptom-limited Exercise Duration as an Indicator of Exercise Capacity [ Time Frame: Application 45 minutes prior to exercise ]
      Subjects will walk on the treadmill as long as they can tolerate, symptom-limited.
    • Time-to-onset of 1mmST depression [ Time Frame: Application 45 minutes prior to exercise ]
      Continuous ECG will be recorded during exercise. Data will be interpreted by a board-certified cardiologist.
    • Time-to-onset, and severity, of angina or angina equivalent symptoms [ Time Frame: Application 45 minutes prior to exercise ]
      Onset of angina or angina-equivalent symptoms, severity (numerical score 1 to 10, where 10 is the worst intensity and 1 is the least), as well as descriptive quality, will be assessed from beginning of exercise.
    • Maximal ST Depression [ Time Frame: Applicaiton 45 minutes prior to exercise ]
      Exercise ECG data will be interpreted by a board certified cardiologist to assess maximal ST depression.
    • Peak rate-pressure product and maximal estimated workload (in METS) during ETT [ Time Frame: Application 45 minutes prior to exercise ]
      Peak rate-pressure and maximal estimated workload will be analyzed.
    • Magnitude of reversible perfusion defect in SPECT perfusion study with wall motion assessment (phase 2) [ Time Frame: Application 45 minutes prior to exercise ]
      Images will be processed and analyzed using

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: University of Cincinnati

      Dates:
      Date Received: October 28, 2010
      Date Started: October 2010
      Date Completion:
      Last Updated: June 23, 2015
      Last Verified: June 2015