A Randomized, Placebo-Controlled, Cross-Over Study to Assess the Safety and Efficacy of TOPical CAPsaicin With Stable Angina (TOPCAP)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 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
排除标准
- •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
研究组 & 干预措施
0.1% Capsaicin Cream
0.1% capsaicin cream spread 8cm x 15cm on abdomen, once, 45 minutes prior to exercise
干预措施: Capsaicin (Drug)
Placebo Cream
Inactive cream, 4cm spread 8cm x 15cm on the abdomen, once, 45 minutes prior to exercise
干预措施: Placebo cream (Other)
结局指标
主要结局
Symptom-limited Exercise Duration as an Indicator of Exercise Capacity
时间窗: 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
时间窗: 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
时间窗: Application was 45 minutes prior to exercise
Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.
Maximal ST Depression
时间窗: 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)
时间窗: 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)
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Neal Weintraub
Professor
University of Cincinnati