Efficacy of Topical Capsaicin Cream for Stable Angina

Phase 3

Terminated

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 Description: 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.

Recruitment & Eligibility

Inclusion Criteria

> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress
documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD >50%
Canadian Cardiovascular (CV) Class I-III
Receiving medical therapy for > or = 2 months
Ability to perform Bruce Protocol treadmill test
non-pregnant female

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
0.1% Capsaicin Cream	Capsaicin	0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
Placebo Cream	Placebo cream	Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise

Primary Outcome Measures

Name	Time	Method
Maximal ST Depression	Application was 45 minutes prior to exercise	Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity	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	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	Application was 45 minutes prior to exercise	Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Maximal Estimated Workload (in METS)	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)	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.	Application was 45 minutes prior to exercise	Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.