Trial Outcomes & Findings for Chest Pain Perception and Capsaicin Sensitivity in Patients With Acute Cardiac Ischemia (NCT NCT02346916)

Results Overview

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")

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

30 minutes

Results posted on

2021-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac Catheterization Patients All subjects will undergo the cutaneous capsaicin test at the time of the study visit; this included a one inch ribbon of Capzasin-HP Cream (0.1%) 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Catheterization Patients n=20 Participants 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. Capsaicin: 1 inch ribbon of Capzasin-HP 0.1% will be a
Age, Continuous	58.70 years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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")

Outcome measures

Outcome measures
Measure	Cardiac Catheterization Patients n=20 Participants All subjects will undergo the cutaneous capsaicin test at the time of the study visit; this included a one inch ribbon of Capzasin-HP Cream (0.1%) 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.
Capsaicin Sensitivity	2.05 score on a scale Standard Deviation 1.90

SECONDARY outcome

Timeframe: 2 hours

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.

Outcome measures

Outcome measures
Measure	Cardiac Catheterization Patients n=20 Participants All subjects will undergo the cutaneous capsaicin test at the time of the study visit; this included a one inch ribbon of Capzasin-HP Cream (0.1%) 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.
Chest Pain	2.50 score on a scale Standard Deviation 2.72

Adverse Events

Cardiac Catheterization Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa B Scribani

Bassett Healthcare Network Research Institute

Phone: 6075477635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place