Chest Pain Perception and Capsaicin Sensitivity
Information source: Bassett Healthcare
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chest Pain
Intervention: Capsaicin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bassett Healthcare Official(s) and/or principal investigator(s):
Dhananjai Menzies, MD, Principal Investigator, Affiliation: Bassett Healthcare
Overall contact:
Catherine Gilmore, RN, Phone: 607-547-7926, Email: catherine.gilmore@bassett.org
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.
Clinical Details
Official title: Chest Pain Perception and Capsaicin Sensitivity
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Capsaicin sensitivity
Secondary outcome: Chest pain score during PCI
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Catherine Gilmore, RN, Phone: 607-547-7926, Email: catherine.gilmore@bassett.org
Bassett Healthcare Network, Cooperstown, New York 13326, United States; Recruiting
Catherine Gilmore, RN, Phone: 607-547-7926, Email: catherine.gilmore@bassett.org
Jennifer Victory, RN, Phone: 607-547-6965, Email: jennifer.victory@bassett.org
Dhananjai Menzies, MD, Principal Investigator
Patrick McNulty, MD, Sub-Investigator
Additional Information
Starting date: April 2013
Last updated: January 21, 2015
|
