Coronary Microvascular Dysfunction in Chronic Coronary Syndrome - Invasive Assessment With Thermo-dilution Technique in the LAD and Biobanking in an All-comer Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Rate of all-cause mortality, MI and/or hospitalization due to CHF
研究概览
简要总结
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).
The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF.
详细描述
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital after written informed consent has been obtained and before the coronary anatomy is known. Blood sampling is performed from the arterial sheath before coronary angiography. The coronary angiography is done according to clinical practice. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the LAD (methods below). Interventions of epicardial lesions are then performed at the percutaneous coronary intervention (PCI)-operators discretion.
Fractional Flow Reserve (FFR), Coronary Flow Reserve(CFR) and IMR measurements
All indices FFR, CFR and IMR are measured in the left anterior descending artery (LAD). The flow measurements shall be obtained before PCI in the LAD. Further assessment of flow in LAD after PCI are optional. Flow measurements in the right coronary artery and circumflex lesions are optional.
Flow measurements:
A coronary guidewire with pressure and temperature sensors (PressurewireX, Abbott Inc, Calif., USA) is advanced in the LAD. The thermistor is placed > 70 mm from the catheter-tip and three millilitres of cold saline is injected into the LAD three times through the guiding catheter and thermo-dilution resting curves in triplicate are obtained. The patient then receives an intravenous infusion of adenosine (167 µg/kg/min) during approximately two minutes to induce stable hyperaemia. Again, three millilitres of cold saline is injected into the LAD through the guiding catheter and hyperaemic thermos-dilution curves in triplicate are obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with stable angina pectoris or suspected angina pectoris who are scheduled for coronary angiography
- •Age 18 years - 85 years
- •Life expectancy >2 years
排除标准
- •Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-ST-elevation myocardial infarction [NSTEMI] and unstable angina pectoris)
- •Known CHF
- •Prior heart transplantation
- •Prior coronary artery by-pass grafting
- •Hypertrophic cardiomyopathy (Septum >15 mm)
- •Valvular disease
- •Not eligible for coronary angiogram
- •Cancer within three years of admission
- •Peri-myocarditis
- •Atrial fibrillation with heart beats per minute >120
结局指标
主要结局
Rate of all-cause mortality, MI and/or hospitalization due to CHF
时间窗: Study completion, approximately 5 years
Cumulative rate of all-cause mortality, MI and/or hospitalization due to CHF at study completion
次要结局
- Rate of all-cause mortality(Study completion, approximately 5 years)
- Rate of hospitalization due to CHF.(Study completion, approximately 5 years)
- Rate of all-cause mortality and/or MI(Study completion, approximately 5 years)
- Rate of MI(Study completion, approximately 5 years)
- Rate of stroke(Study completion, approximately 5 years)
- Rate of ischemic stroke(Study completion, approximately 5 years)
- Rate of unscheduled revascularization(Study completion, approximately 5 years)
研究者
Jonas Persson
Senior Consultant, MD, PhD
Karolinska Institutet