Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Coronary flow reserve
研究概览
简要总结
This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.
详细描述
This study will include patients with chronic total occlusion (CTO) of one coronary artery who will undergo the recanalization of the CTO. Before the procedure, myocardial viability, ischemia, functional parameters of the collateral donor blood vessels, echocardiography, and quality of life will be assessed. After the recanalization, these parameters will be assessed again 24h and 6 months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients over the age of 18 with signed informed consent to participate in the study
- •Presence of one CTO on native coronary arteries (with TIMI 0 flow)
- •Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present):
- •Symptoms of typical stable angina
- •Presence of inducible ischemia in the territory of the occluded artery
- •Presence of viable myocardium in the territory of the occluded artery
- •The diameter of the occluded artery ≥2.5mm
排除标准
- •Acute coronary syndrome in the past month
- •Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months
- •Contraindications for implanting the drug-eluting stents
- •Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow)
- •Severe tortuosity or calcifications of the coronary arteries
- •Left ventricle aneurysm
- •Previous coronary artery bay-pass graft or any other cardiac surgery
- •Previous myocardial infarction in the coronary artery territory different from the CTO
- •Ejection fraction of the left ventricle less than 30%
- •Permanent atrial fibrillation
- •Pregnancy
- •Patients with known allergy to iodine contrast that cannot be controlled with medication
- •Patients who are unable or unwilling to cooperate and come for check-up visits
- •Life expectancy less than a year
- •Hemorrhagic diathesis, coagulopathy, or rejection of blood transfusion
研究组 & 干预措施
Patients with chronic total occlusion of the coronary artery
In each patient before the PCI procedure, the investigators will assess myocardial viability, functional parameters of collateral blood vessels, and quality of life. 24h and 6 months after the procedure these parameters will be reevaluated as well as functional parameters of the treated coronary artery.
干预措施: percutaneous coronary intervention (Procedure)
结局指标
主要结局
Coronary flow reserve
时间窗: six months
Change in coronary flow reserve of the collateral donor vessel (after PCI as compared to values before PCI) will be regarded as primary outcome measure
次要结局
- Coronary flow velocity reserve(six months)
- Wall Motion Score Index (WMSI)(six months)
- Change from Baseline Stable Angina questionnaire (SAQ) at 6 months(six months)
研究者
Milan Dobric
Assistant professor
University of Belgrade