Clinical trial NCT01231750: Efficacy of Topical Capsaicin Cream for Stable Angina
Official title: A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stable Angina
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2010-11-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
timeFrame: Application was 45 minutes prior to exercise
measure: Time-to-onset of 1mm ST Segment Depression
timeFrame: Application was 45 minutes prior to exercise
measure: Time-to-onset of Angina or Angina Equivalent Symptoms
timeFrame: Application was 45 minutes prior to exercise
measure: Maximal ST Depression
timeFrame: Application was 45 minutes prior to exercise
measure: Maximal Estimated Workload (in METS)
timeFrame: Application was 45 minutes prior to exercise
measure: Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)
timeFrame: Phase 2 was not done.
measure: Severity of Angina Was Measured.
timeFrame: Application was 45 minutes prior to exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians, Inc
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Faisal M Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: