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临床试验/NCT06702748
NCT06702748进行中(未招募)不适用

Research on New Technologies for the Diagnosis and Treatment of Cardiovascular Diseases-Multi-parameter Noninvasive Early Diagnosis of Coronary Microvascular Diseases Series I: Clinical Study Protocol for a New Method of Evaluating Coronary Microvessels Based on Coronary IMR Calculated from Coronary Angiography Images

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
452
试验地点
1
主要终点
major adverse cardiac events

研究概览

简要总结

The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.

The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention.

Participants will answer survey questions about their clinical outcomes for 2 years by telephone.

详细描述

This study was a retrospective, multicenter observational investigation and approved by the local Human Research Ethics Committee and conducted in accordance with the principles outlined in the Helsinki Declaration.Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI were eligible for inclusion in the study. Exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification.

Angiography-derived index of microcirculatory resistance was measured in the target vessel treated with RA pre-PCI and post-PCI and blinded and performed by an independent core laboratory.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI

排除标准

  • target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification

结局指标

主要结局

major adverse cardiac events

时间窗: 24 months after PCI

the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina

次要结局

  • target vessel failure(24 months after PCI)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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