Chest Pain Perception and Capsaicin Sensitivity in Patients With Acute Cardiac Ischemia

NCT ID: NCT02346916

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-08-31

Brief 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).

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 urgent or emergent balloon angioplasty of an acute 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. This study is designed to be a companion project to Project 1029 Chest Pain Perception and Capsaicin Sensitivity, which is collecting the same data from clinically stable patients undergoing elective cardiac catheterization.

Conditions

Chest Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cardiac Catheterization Patients

Subjects will undergo the cutaneous capsaicin test at the time of the study visit. 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, from 0 ("no discomfort") to 10 ("the worst discomfort imaginable"). The cream will then be removed by washing the affected arm with cold water. 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. This method should allow an individual's subjective sensitivity to the TRPV1-mediated noxious stimulus of myocardial ischemia to be compared with his/her sensitivity to the TRPV1-mediated noxious stimulus of cutaneous capsaicin in extra-cardiac tissues.

Group Type: OTHER

Capsaicin

Intervention Type: DRUG

1 inch ribbon of Capzasin-HP 0.1% will be applied to the forearm for 30 minutes

Interventions

Capsaicin

1 inch ribbon of Capzasin-HP 0.1% will be applied to the forearm for 30 minutes

Intervention Type: DRUG

Other Intervention Names

Capzasin-HP 0.1%

Eligibility Criteria

Inclusion Criteria

Subjects will consist of patients who have undergone clinically-indicated PCI for the treatment of coronary artery disease. This study will include clinically unstable patients, such as those undergoing emergency percutaneous coronary intervention (PCI) for acute myocardial infarction, etc.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bassett Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Dhananjai Menzies, MD

Attending Physician - Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dhananjai Menzies, MD

Role: PRINCIPAL_INVESTIGATOR

Bassett Healthcare

Locations

Bassett Healthcare Network

Cooperstown, New York, United States

Countries

United States

Other Identifiers

1054

Identifier Type: -

Identifier Source: org_study_id