Chest Pain Perception and Capsaicin Sensitivity

NCT02346903 | Completed Results

• 1 other identifier: 1029
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Chest Pain Score During PCI

  approximately 1 hour

Study Arms (1)

Cardiac Catheterization Patients

OTHER

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.

Drug: Capsaicin

Interventions

Capsaicin DRUG

one inch ribbon of Capzasin -HP applied to forearm for 30 minutes

Also known as: Capzasin-HP 0.1%

Cardiac Catheterization Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will consist of patients who have undergone clinically-indicated percutaneous coronary intervention (PCI) for the treatment of coronary artery disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Chest Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Melissa B Scribani
• Organization: Bassett Healthcare Network Research Institute

melissa.scribani@bassett.org

6075477635

Study Officials

• Dhananjai Menzies, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician - Cardiology

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 27, 2015
• Study Start: April 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

US (1)