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

November 21, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

452

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • 88 Jiefang Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Coronary microvascular dysfunction
angio-IMR>=25
Non-Coronary microvascular dysfunction
Angio-IMR<25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target vessel failure
Time Frame: 24 months after PCI
composed of cardiac death, target vessel myocardial infarction, target vessel revascularization
24 months after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20220940-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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