Chest Pain Perception and Capsaicin Sensitivity
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|ClinicalTrials.gov Identifier: NCT02346903|
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : March 4, 2021
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain||Drug: Capsaicin||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chest Pain Perception and Capsaicin Sensitivity|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
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.
one inch ribbon of Capzasin -HP applied to forearm for 30 minutes
Other Name: Capzasin-HP 0.1%
- 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")
- Chest Pain Score During PCI [ Time Frame: approximately 1 hour ]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
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 ClinicalTrials.gov identifier (NCT number): NCT02346903
|United States, New York|
|Bassett Healthcare Network|
|Cooperstown, New York, United States, 13326|
|Principal Investigator:||Dhananjai Menzies, MD||Bassett Healthcare|