Stable Angina
Conditions
Brief summary
The purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.
Detailed description
Patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ECG for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). Patients will be monitored for exercise tolerance, anginal symptoms, ECG for ischemia/arrhythmia, and hemodynamic responses.
Interventions
DRUGCapsaicin
0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
OTHERPlacebo cream
cream, 4cm spread over 8cm x 15cm area of skin
Sponsors
University of Cincinnati
Neal Weintraub
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress * documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD \>50% * Canadian Cardiovascular (CV) Class I-III * Receiving medical therapy for \> or = 2 months * Ability to perform Bruce Protocol treadmill test * non-pregnant female
Exclusion criteria
* unstable angina * revasc within 2 months * Myocardial infarction (MI) within 2 months * congestive heart failure (CHF) hospitalization within 2 months * New York Heart Association (NYHA) class III or IV * left ventricular ejection fraction (LVEF) \< 25% * abnormal ECG; Acute changes on ECG * Currently receiving treatment with investigational drugs/devices * Uncontrolled hypertension * contraindication to exercise stress testing * allergy to red peppers or capsaicin * skin deformity, scar, or rash at application site * abdominal surgery within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom-limited Exercise Duration as an Indicator of Exercise Capacity | Application was 45 minutes prior to exercise | Subjects walked on the treadmill as long as they could tolerate, symptom-limited. |
| Time-to-onset of 1mm ST Segment Depression | Application was 45 minutes prior to exercise | Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist. |
| Time-to-onset of Angina or Angina Equivalent Symptoms | Application was 45 minutes prior to exercise | Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise. |
| Maximal ST Depression | Application was 45 minutes prior to exercise | Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression. |
| Maximal Estimated Workload (in METS) | Application was 45 minutes prior to exercise | Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT). |
| Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2) | Phase 2 was not done. | Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment. |
| Severity of Angina Was Measured. | Application was 45 minutes prior to exercise | Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least. |
Countries
United States
Participant flow
Recruitment details
Recruitment goal not met.
Pre-assignment details
Inclusion and exclusion criteria proved a large screening volume to yield few participants.
Participants by arm
| Arm | Count |
|---|---|
| 0.1% Capsaicin Cream First, Then Placebo Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise | 3 |
| Placebo First, Then 0.1% Capsaicin Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise
Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | 0.1% Capsaicin Cream First, Then Placebo | Placebo First, Then 0.1% Capsaicin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)
Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.
Time frame: Phase 2 was not done.
Primary
Maximal Estimated Workload (in METS)
Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).
Time frame: Application was 45 minutes prior to exercise
Population: Data collected are no longer accessible.
Primary
Maximal ST Depression
Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.
Time frame: Application was 45 minutes prior to exercise
Population: Data collected are no longer accessible.
Primary
Severity of Angina Was Measured.
Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.
Time frame: Application was 45 minutes prior to exercise
Primary
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
Subjects walked on the treadmill as long as they could tolerate, symptom-limited.
Time frame: Application was 45 minutes prior to exercise
Population: Data collected are no longer accessible.
Primary
Time-to-onset of 1mm ST Segment Depression
Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.
Time frame: Application was 45 minutes prior to exercise
Population: Data collected are no longer accessible.
Primary
Time-to-onset of Angina or Angina Equivalent Symptoms
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Time frame: Application was 45 minutes prior to exercise
Population: Data collected are no longer accessible.