Chest Pain
Conditions
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.
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 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.
Interventions
DRUGCapsaicin
one inch ribbon of Capzasin -HP applied to forearm for 30 minutes
Sponsors
Bassett Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will consist of patients who have undergone clinically-indicated percutaneous coronary intervention (PCI) for the treatment of coronary artery disease.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capsaicin Sensitivity | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest Pain Score During PCI | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | Cardiac Catheterization Patients | — |
|---|---|---|
| Age, Continuous | 64.80 Years STANDARD_DEVIATION 8.38 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 99 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 75 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 99 |
| other Total, other adverse events | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
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)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiac Catheterization Patients | Capsaicin Sensitivity | 2.47 score on a scale | Standard Deviation 2.15 |
Secondary
Chest Pain Score During PCI
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
Time frame: approximately 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiac Catheterization Patients | Chest Pain Score During PCI | 2.90 score on a scale | Standard Deviation 2.92 |