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

NCT ID: NCT06702748

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Arterial Disease (CAD) Coronary Microvascular Dysfunction (CMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Coronary microvascular dysfunction

angio-IMR\>=25

No interventions assigned to this group

Non-Coronary microvascular dysfunction

Angio-IMR\<25

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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88 Jiefang Road

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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20220940-3

Identifier Type: -

Identifier Source: org_study_id

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