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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346916
• Other study ID #: 1054
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2021
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	Bassett Healthcare Network	Cooperstown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bassett Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsaicin Sensitivity	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")	30 minutes
Secondary	Chest Pain	Patients are asked to rate their chest pain on a scale of 0 "No pain" to 10 "Worst pain imaginable" during balloon inflation during PCI.	2 hours