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临床试验/NCT06834828
NCT06834828已完成不适用

Prevalence of Cusp Asymmetry , Coronary Ostial Eccentricity in Patients Undergoing Trans Catheter Aortic Valve Implantation and Their Impact on Coronary Ostial OverlaP Risk Assessment: an Egyptian CO-OPRA Cohort Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Coronary Ostia Overlap with neo-commissures

研究概览

简要总结

The goal of this observational study is to measure the prevalence of Cusps asymmetry, coronary Ostial eccentricity in patients with severe aortic stenosis undergoing Trans-catheter Aortic Valve Implantation (TAVI) and measure the degree of coronary ostia overlap with trans-catheter neo-commissure. The main question it aims to answer is:

Do coronary ostial eccentricity or cusp asymmetry have impact on coronary ostia overlap with trans-catheter neo-commissure? Participants already taking TAVI as part of their regular medical care for severe symptomatic aortic stenosis will do post procedural ECG-gated non contrast Multi-detector Computed Tomographic Angiography (MDCTA).

详细描述

All patients will be subjected to:

Pre-procedural data:

  1. Proper history taking including:
  • Age.
  • Sex
  • Body weight, height, and calculated body mass index
  • Previous related medical history (Hypertensive, Diabetic, Rheumatic heart disease, Peripheral vascular disease, Cerebrovascular disease, Chronic kidney disease, Chronic lung disease.)
  • Previous coronary artery disease (completely revascularized or non-revascularized)
  • Previous related surgical history (Surgical valve replacement, Coronary artery bypass graft surgery (CABG) or PCI, Peripheral vascular stenting or bypass graft surgery and carotid stenting or endarterectomy).
  1. 12-lead surface electrocardiogram (ECG):
  • Intrinsic rhythm.
  • PR interval duration.
  • QRS duration.
  • Presence or absence of bundle branch block.
  • Baseline ischemic ECG changes (Q waves, ST segment depression or elevation and T wave inverted or flat).
  1. Transthoracic echocardiography:

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation

排除标准

  • •severe Aortic stenosis with bicuspid leaflets aortic valve
  • •severe Aortic stenosis undergoing surgical aortic valve replacement

结局指标

主要结局

Coronary Ostia Overlap with neo-commissures

时间窗: With in 30 days from indexed procedure

Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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