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Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231750
Recruitment Status : Terminated (Unable to identify study population to achieve number expected)
First Posted : November 1, 2010
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
University of Cincinnati
Information provided by (Responsible Party):
Neal Weintraub, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Stable Angina Drug: Capsaicin Other: Placebo cream Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: 0.1% Capsaicin Cream
0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
Drug: Capsaicin
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Other Name: capsaicin cream 0.1%, generic

Placebo Comparator: Placebo Cream
Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
Other: Placebo cream
cream, 4cm spread over 8cm x 15cm area of skin
Other Name: cream, placebo

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. Severity of Angina Was Measured. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231750

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United States, Ohio
University of Cincinnati Physicians, Inc
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Neal Weintraub
University of Cincinnati
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Principal Investigator: Faisal M Khan, MD University of Cincinnati
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Responsible Party: Neal Weintraub, Professor, University of Cincinnati Identifier: NCT01231750    
Other Study ID Numbers: UC 060559
First Posted: November 1, 2010    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: June 25, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs