A New Classification and Interventional Therapy for Coronary Artery Ectasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebral events (MACCEs)
研究概览
简要总结
This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.
详细描述
Coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. Clinical symptoms include angina, myocardial infarction and sudden death.At present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.Most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.As a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.By comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.The purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Male or non-pregnant female aged ≥18 years;
- •Coronary artery ectasia was confirmed by coronary CT or coronary angiography;
- •The patient (or guardian) is fully aware of the study process and signs the informed consent;
- •Patients were able to undergo subsequent follow-up.
排除标准
- •Congenital coronary artery fistula;
- •kawasaki disease;
- •Treponema pallidum or lyme treponema;
- •Primary lymphoma;
- •Coronary artery pseudoaneurysm;
- •Acute infectious disease or autoimmune disease;
- •Hematological Disease;
- •Severe liver and kidney dysfunction (AMI one week later, alanine transaminase ≥3 times the upper limit of normal value; Creatinine clearance rate ≤30ml/min or blood creatinine ≥2.5mg/dl);
- •Unstable craniocerebral disease;
- •Severe cognitive impairment (dementia or severe mental illness);
- •Patients with severe physical disabilities who cannot be followed up regularly;
- •Other serious uncontrolled systemic diseases;
- •Female patient who is ready to become pregnant, already pregnant or nursing;
- •Contraindications to percutaneous coronary intervention (PCI) : for patients at high risk of massive bleeding in the digestive tract, intracranial and other areas, or allergic to contrast agents;
- •Cannot tolerate dual antiplatelet therapy for at least 1 year;
- •Age < 18 years old;
- •Patients who are unable or unwilling to sign informed consent
结局指标
主要结局
Major adverse cardiac and cerebral events (MACCEs)
时间窗: 6 months after treatment
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
次要结局
- Changes in drug use(6 months after treatment)
- Changes in coronary artery aneurysm diameter(6 months after treatment)
- Changes in CCS grade(6 months after treatment)
研究者
Shubin_Qiao
Director,Head of cardiology department
China National Center for Cardiovascular Diseases