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Unable to identify study population to achieve number expected
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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1% Capsaicin Cream | Active Comparator | 0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise |
|
| Placebo Cream | Placebo Comparator | Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom-limited Exercise Duration as an Indicator of Exercise Capacity | Subjects walked on the treadmill as long as they could tolerate, symptom-limited. | Application was 45 minutes prior to exercise |
| Time-to-onset of 1mm ST Segment Depression | Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist. | Application was 45 minutes prior to exercise |
| Time-to-onset of Angina or Angina Equivalent Symptoms | Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise. | Application was 45 minutes prior to exercise |
| Maximal ST Depression | Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression. | Application was 45 minutes prior to exercise |
| Maximal Estimated Workload (in METS) | Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT). | Application was 45 minutes prior to exercise |
| 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. | Phase 2 was not done. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faisal M Khan, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Physicians, Inc | Cincinnati | Ohio | 45219 | United States |
Inclusion and exclusion criteria proved a large screening volume to yield few participants.
Recruitment goal not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo First, Then 0.1% Capsaicin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Symptom-limited Exercise Duration as an Indicator of Exercise Capacity | Subjects walked on the treadmill as long as they could tolerate, symptom-limited. | Data collected are no longer accessible. | Posted | Application was 45 minutes prior to exercise |
|
18 months
Adverse events were assessed, but none observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Faisal Khan | University of Cincinnati | 513-558-4272 | faisal.khan@uc.edu |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Placebo cream | Other | cream, 4cm spread over 8cm x 15cm area of skin |
|
|
| Application was 45 minutes prior to exercise |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Time-to-onset of 1mm ST Segment Depression | Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist. | Data collected are no longer accessible. | Posted | Application was 45 minutes prior to exercise |
|
|
| Primary | Time-to-onset of Angina or Angina Equivalent Symptoms | Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise. | Data collected are no longer accessible. | Posted | Application was 45 minutes prior to exercise |
|
|
| Primary | Maximal ST Depression | Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression. | Data collected are no longer accessible. | Posted | Application was 45 minutes prior to exercise |
|
|
| Primary | Maximal Estimated Workload (in METS) | Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT). | Data collected are no longer accessible. | Posted | Application was 45 minutes prior to exercise |
|
|
| 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. | Posted | Phase 2 was not done. |
|
|
| 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. | Not Posted | Application was 45 minutes prior to exercise |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 4 | 0 | 4 |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004364 | Pharmaceutical Preparations |