Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- safety of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major or minor bleeding
研究概览
简要总结
Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as a dilatation with a diameter of 1.5 times the adjacent normal coronary artery . Its prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .
Coronary ectasia likely represents an exaggerated form of expansive vascular remodelling (i.e. excessive expansive remodelling) in response to atherosclerotic plaque growth .
CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM have low incidence of CAE. This may be due to down regulation of MMP with negative remodelling in response to atherosclerosis . Smoking appears to be more common in patients with CAE than in those with coronary artery disease (CAD).
The angiographic classification for CAE (described by Markis et al.) categorizes the severity based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3 arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse single arterial ectasia; Type 4: Localized or segmental ectasia .
Stable angina is the most common presentation in patients with CAE . Patients with CAE without stenosis had positive results during treadmill exercise tests. ST-elevation myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal embolization or occlusion of ectatic segment with thrombus.
Medical management for CAE is a controversial area as there is lack of evidence based medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was suggested in all patients because of coexistence of CAE with obstructive coronary lesions in the great majority of patients and the observed incidence of myocardial infarction, even in patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been evaluated in prospective randomized studies. Based on the significant flow disturbances within the ectatic segments, chronic anticoagulation with warfarin as main therapy was suggested
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with suspected CAD who are referred for elective coronary angiography
排除标准
- •Previous admission with an acute coronary event, previous PCI or CABG.
- •History of bleeding tendency or those with high bleeding risk according to the HAS-BLED bleeding risk score
研究组 & 干预措施
Asprin
Patient will receive dual anti platelet asprin And clopidogrel
干预措施: Antiplatelet Agents (Drug)
Clopidogrel
Patient will receive dual anti platelet asprin And clopidogrel
干预措施: Antiplatelet Agents (Drug)
Warfarin
Patient will receive oral anticoagulation
干预措施: Anticoagulants (Drug)
Novel oral anticoagulant
Patient will receive oral anticoagulation
干预措施: Anticoagulants (Drug)
结局指标
主要结局
safety of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major or minor bleeding
时间窗: 6 months
safety endpoints of occurance of major or minor bleeding
Efficacy of dual antiplatelet therapy vs oral anticoagulants in patients with CAE - occurance of major adverse cardiovascular events
时间窗: 6 months
Efficacy endpoints defined as the occurance of major adverse cardiovascular events (MACE)
次要结局
未报告次要终点
研究者
Martina Gamil Fathi
Principal Investigator
Assiut University