Coronary Artery Bypass Graft Surgery (CABG)NCT06844721
Association Between μFR And CABG Outcomes
An observational study of Coronary Artery Bypass Graft Surgery (CABG), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery (CABG)
- How many people
- 945 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2008to 31 Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3VD patients who underwent isolated off-pump CABG
Who may be able to join
- patients who underwent isolated off-pump CABG for 3-vessel disease,
- patients who underwent preoperative coronary angiography that fits for μFR analysis,
Who cannot join
- Patients who underwent on-pump CABG
- Patients in whom quality of preoperative coronary angiography did not fit for μFR analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- quantitative flow reserve, coronary artery bypass graft surgery (CABG), graft patency, clinical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency rate
1 year graft patency rate after surgery
Measured: 1 year after surgery
Number of participants with Long-term all-cause mortality
All-cause mortality indicates death from any cause during follow-up
Measured: 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
MACE includes death, repeat revascularization and non-fatal myocardial infraction
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jan 2008
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft Surgery (CABG)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 945 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Ho Young Hwang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844721
- Sponsor's protocol ID
- H-2212-151-1390
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available.
Publications
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.
PubMed 37870715Tu 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.
PubMed 33660921Tonino 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.
PubMed 19144937Pijls 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.
PubMed 17531660Hwang 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.
PubMed 41093449
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Murray Law-Based Angiography-Derived Fractional Flow Reserve and Outcomes After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06844721
- Acronym / sponsor ID
- H-2212-151-1390
- Keywords
- quantitative flow reserve, coronary artery bypass graft surgery (CABG), graft patency, clinical outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3VD patients who underwent isolated off-pump CABG
Key inclusion criteria (2 listed)
- patients who underwent isolated off-pump CABG for 3-vessel disease,
- patients who underwent preoperative coronary angiography that fits for μFR analysis,
Key exclusion criteria (2 listed)
- Patients who underwent on-pump CABG
- Patients in whom quality of preoperative coronary angiography did not fit for μFR analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft patency rate
Time frame: 1 year after surgery
1 year graft patency rate 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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 37870715Kotoku 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.
- Results publication: PubMed 33660921Tu 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.
- Results publication: PubMed 19144937Tonino 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.
- Results publication: PubMed 17531660Pijls 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.
- Derived from this study: PubMed 41093449Hwang 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.
- Individual participant dataSharing planned: Yes. There is a plan to make individual participant data (IPD) and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft Surgery (CABG), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency rate (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06844721, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.