Primary outcome: Primary: Capsaicin Sensitivity — 2.47 score on a scale
Study Design & Population
Study type
Interventional
Phase
N/A
Interventions
Capsaicin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Bassett Healthcare
Primary completion
Aug 2015
Outcome Measures
Outcome
Result
p-value
PRIMARY Capsaicin Sensitivity
2.47
—
SECONDARY Chest Pain Score During PCI
2.90
—
Summary
The purpose of this study is to determine whether there is a positive correlation between the ability to sense chest pain in the context of myocardial ischemia and the ability to sense discomfort associated with the topical application of the TRPV1 agonist capsaicin (the active ingredient on hot chili peppers). Patients undergoing clinical elective balloon angioplasty of a coronary stenosis will be asked to quantify the subjective intensity of any chest pain they feel during a standardized episode of myocardial ischemia produced by a one-minute coronary balloon occlusion, using a previously-validated numeric rating scale. The same patients will subsequently be asked to grade the subjective intensity of cutaneous discomfort resulting from application of a capsaicin-containing patch (Capzasin-HP Cream, an over-the-counter product approved for topical application to treat muscle and joint aches) to the forearm. The goal will be to determine whether an association can be demonstrated between the subjective perception of ischemic chest pain during coronary balloon occlusion and cutaneous capsaicin sensitivity. Such an association could have considerable clinical value, as it might allow physicians to prospectively assess an individual's ability to perceive myocardial ischemia/infarction by assessing his/her subjective response to the topical application of capsaicin.
Eligibility Criteria
Inclusion Criteria
Subjects will consist of patients who have undergone clinically-indicated percutaneous coronary intervention (PCI) for the treatment of coronary artery disease.
Exclusion Criteria
Clinically unstable patients, such as those undergoing emergency PCI, patients with documented hypersensitivity to capsaicin will be excluded and patients who have used a capsaicin-based product within the last 3 months will be excluded. Patients in whom it would be inadvisable for any reason to conduct a one-hour research study at a follow-up visit after PCI will also be excluded.
Data sourced from ClinicalTrials.gov (NCT02346903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.