NL-OMON55130招募中不适用
Efficacy of Spinal Cord Stimulation in patients with Refractory Angina Pectoris; a randomized controlled trial - SCRAP trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Refractory Angina Pectoris: - Stable angina pectoris CCS class III or IV,
- •with a minimum of 5 episodes of angina pectoris over the course of one week,
- •during a minimum period of three months prior to screening; - Coronary
- •angiogram (CAG) performed within the last 12 months showing significant
- •coronary artery disease defined as at least one coronary artery stenosis of
- •>75% or 50 - 75% with proven ischaemia (see below), not suitable for
- •revascularisation. Confirmed by one (or two in case of doubt) interventional
- •cardiologist based on CAG images; - Optimal anti-anginal medication. Patients
- •should at least use; b-blocker and/or calcium channel blocker, short- and/or
- •long-acting nitrate. If the patient doesn*t use one of these groups of
- •medication the reason (side-effects) should be clear.
- •- Proven ischemia: - MIBI-SPECT: summed stress score (SSS) of at least 1, in
- •combination with summed difference score (SDS) of at least 1 (1-4 mild
- •ischaemia, > 4 moderate to severe ischaemia); - FFR: < 0.80, with no
- •intervention options (determined by intervention cardiologist); - MRI
- •perfusion: >= 1 segment of subendocardial hypoperfusion during stress perfusion,
- •not present at rest and no matching fibrosis (using 16 segment AHA heart
- •model); - PET: Semi-quantitative measurement: SSS score of at least 1, in
- •combination with SDS score of at least 1 (1-4 mild ischaemia, > 4 moderate to
- •severe ischaemia). Quantitative measurement: reduced myocardial perfusion
- •- No revascularisation (PCI and/or CABG) performed between ischaemia testing
- •and study inclusion.
- •- Age 18 years or older
排除标准
- •- Acute coronary syndrome (ACS) during three month period prior to screening
- •- Life expectancy less than 12 months
- •- Inability to perform a 6-minute walking test
- •- Inability to give informed consent
- •- No proven ischemia (see Inclusion criteria for definition)
- •- Spinal cord disease which could prevent correct positioning of the lead in
- •the epidural space; to be determined by the anaesthesiologist performing the
- •implantation
- •- Anticoagulation therapy that cannot be stopped prior to spinal cord
- •stimulator implantation
- •- Inadequate paresthesia coverage, during implantation, of the thoracic region
- •where angina complaints are localized
- •- Pregnancy
- •- Mild Cognitive Impairment or dementia
- •- Concomitant symptomatic valvular heart disease including severe aortic
- •stenosis and/or regurgitation, severe mitral valve stenosis and/or
- •regurgitation or severe tricuspid valve regurgitation.
研究者
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