ISRCTN09648950已完成不适用
An open label, single-centre, randomized trial of spinal cord stimulation vs percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial
Medtronic Sàrl (Switzerland)0 个研究点目标入组 68 人开始时间: 2008年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
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
- 性别
- All
入选标准
- •1. Patient with limiting angina (Canadian Cardiovascular Society [CCS] III or IV) despite maximally tolerated medical therapy
- •2. Documented coronary artery disease (within the last 9 months prior to baseline), which is
- •unsuitable for conventional revascularisation techniques
- •3. Patient has documented reversible ischaemia on nuclear scan (Tc-99 sestamibi)
- •4. Patient is limited in daily activities, primarily exercise capability, by their anginal pain
- •5. Age 18 or older
- •6. Patient must understand the therapy and give informed consent
- •7. Patient must be available for appropriate follow-up times for length of study
- •8. Non-pregnant women (only women who are post menopausal, surgically sterile or those of
- •child bearing potential who are using an acceptable method of contraception) as safety for
- •use of SCS during pregnancy or delivery has not been established. Acceptable methods of
- •contraception include the following:
- •a. Barrier type devices (e.g. female condom, diaphragm and contraceptive sponge) used only in combination with a spermicide
- •b. Intrauterine devices (IDUs)
- •c. Oral contraceptive agent
- •d. Depro-ProveraTM (medroxyprogesterone acetate)
- •e. Levonorgestrel implants
- •f. Naturally sterile (amenorrheic for at least 1 year) in patients over 50
- •Note: Abstinence, the rhythm method or contraception by the partner alone are NOT acceptable methods of contraception
排除标准
- •1. Patient who is not a candidate for surgical implantation of the spinal cord stimulation system,
- •and/or not a candidate for a PMR procedure and/or unable to use the SCS device appropriately for treatment
- •2. Patient who has had one or more major cardiac events within the last 2 months
- •3. Patient with a myocardial wall thickness <8 mm in the ischaemic area to be treated as verified
- •by echocardiography
- •4. Patient with extensive peripheral vascular disease that precludes vascular access required for
- •5. Patient on intravenous therapy to control their symptoms
- •6. Patient who is unlikely to survive for more than 12 months due to non cardiac condition e.g.
- •7. Patient who has other diseases that are considered of greater clinical significance than the
- •angina pectoris (e.g. inadequately controlled diabetes mellitus, heart failure) that would impact
- •the ability of the clinician to adequately assess the incremental effects of the trial treatment
- •8. Patient with ejection fraction of less than 30% as verified by echocardiography
- •9. Patient with cause of angina other than coronary artery disease (e.g. syndrome X patient)
- •10. Patient who is unable to perform treadmill exercise test per protocol
- •11. Patient who was previously enrolled in this study, or is currently in another clinical study, which will interfere with this protocol
- •12. Patient who has had spinal cord stimulation (SCS) therapy, a transmyocardial laser revascularization (TMLR) or PMR procedure in the past
- •13. Patient with an implanted pacemaker or defibrillator
- •14. Patient who has medical conditions which may require Magnetic Resonance Imaging (MRI)
- •15. Patient with a 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
- •16. Patient with history of alcohol or drug abuse
研究者
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