Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention

Active, not recruiting

• Conditions: Coronary Arterial Disease (CAD); Coronary Microvascular Dysfunction (CMD)

• Registration Number: NCT06702748
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2024-10
• Primary Completion: 2024-10-31
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 452

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major adverse cardiac events	24 months after PCI	the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina

Secondary Outcome Measures

Name	Time	Method
target vessel failure	24 months after PCI	composed of cardiac death, target vessel myocardial infarction, target vessel revascularization

Trial Locations

Locations (1)

88 Jiefang Road; 🇨🇳 Hangzhou, Zhejiang, China