NCT00200070终止3 期
STARTSTIM - Stimulation Therapy for Angina Refractory To Standard Treatments, Interventions and Medications
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 228
- 试验地点
- 8
- 主要终点
- The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
研究概览
简要总结
The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD)
- •classified as Canadian Cardiovascular Society (CCS) angina class III or IV
- •refractory angina despite receiving optimal/maximal medical treatment
- •not a candidate for bypass surgery, angioplasty or stent
排除标准
- •not able to perform exercise treadmill testing
- •previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS)
- •has an implanted pacemaker/defibrillator (ICD)
结局指标
主要结局
The primary endpoint is total exercise time on a treadmill compared between treatment groups at six months.
次要结局
- Secondary outcome measures include exercise time to angina onset and improvement in angina symptoms and cardiovascular function.
研究者
研究点 (8)
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