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Efficacy of Topical Capsaicin Cream for Stable Angina (TOPCAP)

This study has been terminated.
(Unable to identify study population to achieve number expected)
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Neal Weintraub, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01231750
First received: October 28, 2010
Last updated: June 23, 2015
Last verified: June 2015
  Purpose
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 Intervention Phase
Stable Angina
Drug: Capsaicin
Other: Placebo cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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)

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • 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.


Enrollment: 7
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231750

Locations
United States, Ohio
University of Cincinnati Physicians, Inc
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Neal Weintraub
University of Cincinnati
Investigators
Principal Investigator: Faisal M Khan, MD University of Cincinnati
  More Information

Responsible Party: Neal Weintraub, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01231750     History of Changes
Other Study ID Numbers: UC 060559
Study First Received: October 28, 2010
Results First Received: June 25, 2013
Last Updated: June 23, 2015

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2017