Association Between ΜFR and CABG Outcomes

February 19, 2025 updated by: Ho Young Hwang, Seoul National University Hospital

Association Between Murray Law-Based Angiography-Derived Fractional Flow Reserve and Outcomes After Coronary Artery Bypass Grafting

The goal of this observational study is to evaluate the association between Murray law-based quantitative flow reserve and outcomes after coronary artery bypass graft surgery.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The goal of this observational study is to evaluate the association between Murray law-based quantitative flow reserve and outcomes after coronary artery bypass graft surgery. By constructing registry database during 10-year periods, several types of study objectives including 'graft patency' and 'long-term clinical outcomes' will be evaluated.

Study Type

Observational

Enrollment (Actual)

945

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

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

3VD patients who underwent isolated off-pump CABG

Description

Inclusion Criteria:

  1. patients who underwent isolated off-pump CABG for 3-vessel disease,
  2. patients who underwent preoperative coronary angiography that fits for μFR analysis,

Exclusion Criteria:

  1. Patients who underwent on-pump CABG
  2. Patients in whom quality of preoperative coronary angiography did not fit for μFR analysis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft patency rate
Time Frame: 1 year after surgery
1 year graft patency rate after surgery
1 year after surgery
Number of participants with Long-term all-cause mortality
Time Frame: From date of enrollment (operation) until the date of death from any cause, assessed up to 15 years").
All-cause mortality indicates death from any cause during follow-up
From date of enrollment (operation) until the date of death from any cause, assessed up to 15 years").

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of partipiciants with major adverse cardiac events
Time Frame: From date of enrollment (operation) until the date of first documented major events or date of death from any cause, whichever came first, assessed up to 15 years
MACE includes death, repeat revascularization and non-fatal myocardial infraction
From date of enrollment (operation) until the date of first documented major events or date of death from any cause, whichever came first, assessed up to 15 years

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2008

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-2212-151-1390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make individual participant data (IPD) and related data dictionaries available.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

IPD will be shared on reasonable request to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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