NCT04892537Unknown不适用
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Myocardial Blood Flow
研究概览
简要总结
ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
- •Evidence of ischaemia on stress perfusion CMR
- •Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy
排除标准
- •Age<18 years
- •Pregnancy
- •Inability to consent
- •Recent acute coronary syndrome (3 months)
- •Recent revascularisation (6 months)
- •Permanent pacemaker or defibrillator leads in the right heart
- •Severe left ventricular impairment (<25%)
- •Indication for cardiac resynchronisation therapy (CRT)
- •Right atrial pressure ≥15mmHg
- •Life expectancy <1 year
- •Severe renal impairment (eGFR<15)
- •Contraindication to CMR
- •Contraindication to adenosine
- •Ischaemia isolated to inferior wall
- •Ongoing participation in a separate interventional study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo procedure
干预措施: Placebo Procedure (Procedure)
CSR
Active Comparator
Coronary Sinus Reducer implantation
干预措施: Coronary Sinus Reducer (Device)
结局指标
主要结局
Myocardial Blood Flow
时间窗: 6 months
On cardiac MRI, with adenosine stress, millilitres/gram/minute
次要结局
- Angina related quality of life rated by the MacNew questionnaire(6 months)
- SAQ Treatment Satisfaction(6 months)
- Myocardial perfusion reserve (MPR) in ischaemic segments, non ischaemic segments and global MPR(6 months)
- Canadian Cardiovascular Society Class(6 months)
- Angina symptom score(6 months)
- Seattle Angina Questionnaire (SAQ) Angina Frequency(6 months)
- Endocardial:epicardial ratio of stress MBF(6 months)
- Episodes of angina component of angina symptom score(6 months)
- Absolute coronary flow on pressure/temperature wire assessment(6 months)
- Endocardial:epicardial ratio of rest MBF(6 months)
- Myocardial strain(6 months)
- Myocardial scar burden(6 months)
- SAQ Quality of Life(6 months)
- SAQ Angina Stability(6 months)
- Coronary flow reserve (CFR) on pressure/temperature wire assessment(6 months)
- CFR assessed by a pressure and doppler sensor wire(6 months)
- Endocardial:epicardial ratio of MPR(6 months)
- Euro-Qol (EQ-5D-5L) descriptive system(6 months)
- Euro-Qol (EQ-5D-5L) visual analogue scale(6 months)
- Treadmill Exercise Time(6 months)
- Absolute coronary resistance on pressure/temperature wire assessment(6 months)
- Microvascular resistance reserve on pressure/temperature wire assessment(6 months)
- Index of microcirculatory resistance on pressure/temperature wire assessment(6 months)
- Rest myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global rest MBF(6 months)
- Stress myocardial blood flow (MBF) in ischaemic segments, non ischaemic segments and global stress MBF(6 months)
- MPR in ischaemic segments with inferior and inferoseptal segments excluded(6 months)
- MBF in ischaemic segments with inferior and inferoseptal segments excluded(6 months)
- SAQ Angina Physical Limitation(6 months)
研究者
研究点 (5)
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