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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
cream, 4cm spread over 8cm x 15cm area of skin
University of Cincinnati Physicians, Inc
Cincinnati, Ohio, United States
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Time frame: Application was 45 minutes prior to exercise
Time-to-onset of 1mm ST Segment Depression
Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
Time frame: Application was 45 minutes prior to exercise
Time-to-onset of Angina or Angina Equivalent Symptoms
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Time frame: Application was 45 minutes prior to exercise
Maximal ST Depression
Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Time frame: Application was 45 minutes prior to exercise
Maximal Estimated Workload (in METS)
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
Time frame: Application was 45 minutes prior to exercise
Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)
Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
Time frame: Phase 2 was not done.
Severity of Angina Was Measured.
Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.
Time frame: Application was 45 minutes prior to exercise
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