- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346903
Chest Pain Perception and Capsaicin Sensitivity
Study Overview
Detailed Description
Chest discomfort is considered the hallmark of myocardial ischemia and as such is an important clinical warning sign of myocardial infarction (MI). The ability to sense ischemic chest discomfort appears to be impaired in a substantial minority of the population and such individuals are presumably at increased risk for unrecognized MI. While the mechanism(s) responsible for the perception of chest pain associated with myocardial ischemia are still not fully understood, studies suggest that the transient receptor potential vanilloid-1 (TRPV1) plays a key role in this process. This nociceptor, which is known to mediate pain sensation in the skin and elsewhere in the peripheral nervous system, has also been found on the outer surface of the heart and has been shown to respond to ischemic stress in this organ.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Cooperstown, New York, United States, 13326
- Bassett Healthcare Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cardiac Catheterization Patients
Subjects will undergo the cutaneous capsaicin test.
A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm.
Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 ("no discomfort") to 10 ("the worst discomfort imaginable").
The cream will then be removed by washing the affected arm with cold water.
The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods.
Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion.
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one inch ribbon of Capzasin -HP applied to forearm for 30 minutes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capsaicin Sensitivity
Time Frame: 30 minutes
|
Each patient will be asked to rate their discomfort at the application site based on a 10 point numerical rating scale for cutaneous discomfort, ranging from 0 ("no discomfort") to 10 ("the worst discomfort imaginable")
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chest Pain Score During PCI
Time Frame: approximately 1 hour
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patients are asked to rate their chest pain on a scale of 0-10 (0 "no pain", 10 "worst pain imaginable") during balloon inflation during PCI
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approximately 1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dhananjai Menzies, MD, Bassett Healthcare
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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