Randomized Study on SCS for the Treatment of Refractory Angina Pectoris
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction of angina symptoms
研究概览
简要总结
The study aims at assessing safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study.
Sixty patients with refractory angina with new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS;
- subliminal SCS;
- low (non effective) stimulation (control).
Clinical follow-up will be done at 1 and 3 months. Control group patients will then be randomized to paresthesic SCS or subliminal SCS for another 3 months and the 2 groups will be reassessed at 6 months.
详细描述
Aim of the study is to assess safety and efficacy of Spinal Cord Stimulation (SCS) for the treatment of refractory angina pectoris in a single blind, prospective, multicenter study. The study also assesses whether subliminal SCS may be as effective as paresthesic SCS in these patients.
Sixty consecutive patients with refractory angina with a new SCS device implantation will be randomized to one of three treatment groups:
- paresthesic SCS (group 1);
- subliminal SCS (75-80% of paresthesic threshold; group 2);
- low stimulation, consisting of an hour of SCS a day at 0.05 mV intensity, which does not have any significant stimulator effect (sham stimulation, group 3).
Study Procedure
Medical history, clinical data, drug therapy, Angina Canadian Cardiovascular Society (CCS) classification, Seattle Angina Questionnaire (SAQ), quality of life estimation by EuroQoL scale, detailed evaluation of angina attacks (frequency, intensity, duration of episodes; nitrates assumption) according to a structured diary, number of hospitalizations, emergency room (ER) admissions and cardiological visits in the previous 6 months and treadmill exercise stress test results will be obtained at the baseline visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina pectoris refractory to optimal medical therapy, with at least 10 angina episodes in the three weeks previous SCS implant;
- •Documentation of coronary artery disease and reversible myocardial ischaemia;
- •Patient is not a candidate for or refuses surgical or percutaneous coronary revascularization;
- •Availability for follow-up visits;
- •Written informed consent.
排除标准
- •Severe spinal cord diseases that prevent the catheter positioning in the epidural space;
- •No paresthesic coverage of angina pain area during SCS;
- •Unstable angina pectoris;
- •Female patients in fertile age;
- •Enrolment in other studies;
- •Need for anticoagulant therapy;
- •Patients needing diathermy treatment;
- •Life expectancy <12 months.
结局指标
主要结局
Reduction of angina symptoms
时间窗: 1, 3, 6 and 12 months
improvement of quality of life
时间窗: 1, 3, 6 and 12 months
次要结局
- evaluation of adverse events and complications(0, 1, 3, 6 and 12 months)
- Improvement of exercise induced myocardial ischemia(3, 6 and 12 months)