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Clinical Trials/NCT06702748
NCT06702748
Active, not recruiting
Not Applicable

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 site in 1 country452 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Arterial Disease (CAD)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
452
Locations
1
Primary Endpoint
major adverse cardiac events
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

major adverse cardiac events

Time Frame: 24 months after PCI

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

Secondary Outcomes

  • target vessel failure(24 months after PCI)

Study Sites (1)

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