Clinical trial NCT06844721: Association Between ΜFR and CABG Outcomes
Official title: Association Between Murray Law-Based Angiography-Derived Fractional Flow Reserve and Outcomes After Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Bypass Graft Surgery (CABG)
Keywords: quantitative flow reserve
coronary artery bypass graft surgery (CABG)
graft patency
clinical outcomes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2025-02-25
Enrollment: 945
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3VD patients who underwent isolated off-pump CABG

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft patency rate
timeFrame: 1 year after surgery
measure: Number of participants with Long-term all-cause mortality
timeFrame: From date of enrollment (operation) until the date of death from any cause, assessed up to 15 years").
Secondary outcomes:
measure: Number of partipiciants with major adverse cardiac events
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.