Efficacy of Topical Capsaicin Cream for Stable Angina

Study Overview
=================
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.

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

Conditions
-----------------
Stable Angina

Intervention / Treatment
-----------------
* Drug: Capsaicin
* Other: Placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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: unstable angina revasc within 2 months Myocardial infarction (MI) within 2 months congestive heart failure (CHF) hospitalization within 2 months New York Heart Association (NYHA) class III or IV left ventricular ejection fraction (LVEF) < 25% abnormal ECG; Acute changes on ECG Currently receiving treatment with investigational drugs/devices Uncontrolled hypertension contraindication to exercise stress testing allergy to red peppers or capsaicin skin deformity, scar, or rash at application site abdominal surgery within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.1% Capsaicin Cream<br>0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise | Drug: Capsaicin<br>* 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise<br>* Other names: capsaicin cream 0.1%, generic;|
| Placebo Comparator: Placebo Cream<br>Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise | Other: Placebo cream<br>* cream, 4cm spread over 8cm x 15cm area of skin<br>* Other names: cream, placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom-limited Exercise Duration as an Indicator of Exercise Capacity | Subjects walked on the treadmill as long as they could tolerate, symptom-limited. | 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. | 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. | 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. | Application was 45 minutes prior to exercise | 
| Maximal Estimated Workload (in METS) | Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT). | 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. | 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. | Application was 45 minutes prior to exercise |