NCT00157742终止4 期
An Open Single-Centre Parallel Randomised Trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Revascularisation (PMR) in Patients With Refractory Angina Pectoris
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Medtronic
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Improvement in total exercice time following SCS compared to PMR at 12 months
研究概览
简要总结
Randomised trial of Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) in patients with Refractory Angina Pectoris.
Hypothesis: difference in exercise tolerance at 12 months between SCS and PMR
详细描述
The purpose of this open, parallel, single-center prospective, randomised controlled trial is to compare two treatments: Spinal Cord Stimulation (SCS) and Percutaneous Myocardial Laser Revascularisation (PMR) and assess their use and longer term effect in patients with Refractory Angina Pectoris.
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
- None
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
- •Patient limiting angina (CCS III or IV) despite maximally tolerated medical therapy
- •Documented coronary artery disease (within the last 9 months prior baseline), which is unsuitable for conventional revascularisation techniques
- •Patient has documented reversible ischemia on nuclear scan (Tc-99 sestamibi)
- •Patient is limited in daily activities, primarily exercice capability, by their angina pain
- •Age 18 or older
- •Patient must understand the therapy and give informed consent
- •Patient must be available for appropriate follow-up times for length of Study
- •Non pregnant woman
排除标准
- •Not candidate for surgical implantation of SCS and/or not for PMR and/or unable to use SCS device appropriately for treatment
- •Patient who has had one or more major cardiac events within 2 months
- •Patient with myocardial wall thickness< 8 mm in the ischaemic area to be treated as verified by echocardiography
- •Patient with extensive peripheral vascular disease that precludes vascular access required for PMR
- •Patient on intravenous therapy to control their symptoms
- •Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.malignancy
- •patient who has other diseases that are considered of greater clinical significance than the angina pectoris that would impact the ability of the clinician to adequately assess the incremental effects of the trial treatment
- •Patient with ejection fraction of less than 30 % as verified by echocardiography
- •Patient with cause of angina other than coronary artery disease (e.g. syndrome "X" patient)
- •Patient who are unable to perform treadmill exercice test per protocol
- •Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
- •Patient who has has SCS , a TMLR or PMR procedure in the past
- •Patient with an implanted pacemaker or defibrillator
- •Patient who has medical conditions which may require Magnetic resonance Imaging (MRI)
- •Patient with history of dementia or other persisting mental disorders significantly interfering with ability to cooperate or comply with the requirements of the study or comprehend informed consent
- •Patient with history of Alcohol og Drug abuse
结局指标
主要结局
Improvement in total exercice time following SCS compared to PMR at 12 months
次要结局
- Angina measured by the CCS class and the patients subjectives observations
- Morbidity/Mortality
- Quality of life
- Medication consumption
- Difference in myocardial perfusion scanning
- Myocardial ischemia during exercise treadmill testing
- Safety profiles
研究者
研究点 (1)
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