Association Between ΜFR and CABG Outcomes

NCT06844721 | Active Not Recruiting

• 1 other identifier: H-2212-151-1390
• Study Type: observational
• Target: 945
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass Graft Surgery (CABG)

Keywords

quantitative flow reserve; coronary artery bypass graft surgery (CABG); graft patency; clinical outcomes

Outcome Measures

Primary Outcomes (2)

• Graft patency rate

  1 year graft patency rate after surgery

  1 year after surgery

• Number of participants with Long-term all-cause mortality

  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 Outcomes (1)

• Number of partipiciants with major adverse cardiac events

  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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3VD patients who underwent isolated off-pump CABG

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (5)

• Kotoku N, Ninomiya K, Ding D, O'Leary N, Tobe A, Miyashita K, Masuda S, Kageyama S, Garg S, Leipsic JA, Mushtaq S, Andreini D, Tanaka K, de Mey J, Wijns W, Tu S, Piazza N, Onuma Y, Serruys PW. Murray law-based quantitative flow ratio to assess left main bifurcation stenosis: selecting the angiographic projection matters. Int J Cardiovasc Imaging. 2024 Jan;40(1):195-206. doi: 10.1007/s10554-023-02974-z. Epub 2023 Oct 23.

  PMID: 37870715 BACKGROUND

• Tu S, Ding D, Chang Y, Li C, Wijns W, Xu B. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: A novel method based on bifurcation fractal law. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:1040-1047. doi: 10.1002/ccd.29592. Epub 2021 Mar 4.

  PMID: 33660921 BACKGROUND

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

  PMID: 19144937 BACKGROUND

• Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.

  PMID: 17531660 BACKGROUND

• Hwang HY, Ding D, Kang J, Sun P, Sohn SH, Tu S, Koo BK. Association Between Angiography-Derived Murray Law-Based Quantitative Flow Ratio and 1-Year Coronary Artery Bypass Graft Patency. JACC Cardiovasc Interv. 2025 Oct 13;18(19):2326-2334. doi: 10.1016/j.jcin.2025.08.027.

  PMID: 41093449 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 25, 2025
• Study Start: January 1, 2008
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication
• Access Criteria: IPD will be shared on reasonable request to the corresponding author.

Locations

KR (1)