Coronary Artery DiseaseNCT06028165
CABG Based on CT-FFR Versus Conventional Coronary Angiography
A study testing Coronary artery bypass grafting based on conventional coronary angiography and Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve. in people with Coronary Artery Disease, run by Myongji Hospital at 1 site in South Korea.
Trial summary
The aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary artery bypass grafting based on conventional coronary angiography and Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age equal or more than 40
- age equal or less than 80
- patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
- patients who agree to the enrollment
Who cannot join
- Patients with heart failure (left ventricular ejection fraction < 25%)
- patients who have intractable ventricular arrhythmia
- patients who has been treated for cancer
- patients who has infectious disease
- patients who are planned to undergo combined cardiac surgery
- patients who has medical co-morbidity with expected survival less than 1 year
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- patients with a history of previous cardiac surgery
- Patients with chronic renal failure requiring dialysis
- patients who undergo emergency operation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Myongji Hospital
Goyang-si, Gyeonggi-do
Min-Seok Kim, MD, PhD, MSc
About this study
Official title: A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
The aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes between the 2 groups.
Read the detailed description
The CABG-COREA trial is designed as a randomized, controlled trial to recruit 96 patients who undergo coronary artery bypass grafting. Patients were randomized by use of a randomization table. Coronary arteries are revascularized based on conventional coronary angiography (quantitative coronary angiography) or cardiac computed tomography-derived fractional flow reserve according to the randomization result.
The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events).
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary artery bypass grafting based on conventional coronary angiography, Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass grafting based on conventional coronary angiographyProcedure or surgery
Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)
Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.Procedure or surgery
Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.
| Study group | Role | What they receive |
|---|---|---|
| CAG group | Active comparator | Patients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography) Receives: Procedure: Coronary artery bypass grafting based on conventional coronary angiography |
| CT-FFR group | Active comparator | Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve Receives: Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year graft patency rates
postoperative graft patency measured by 1 year postoperative coronary angiography
Measured: 1 year
Secondary outcomes (4)
Overall survival
Overall survival rate at 4 years
Measured: 4 years
Freedom from Cardiac Death
Freedom from cardiac death at 4 years
Measured: 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
Measured: 4 years
Early Angiographic Patency Rates
The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting
Measured: 1.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Oct 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Seok Kim, Myongji Hospital
- Investigators
- Min-Seok Kim, MD, PhD, MSc, Study chair, Cardiovascular Center, Myongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028165
- Sponsor's protocol ID
- MyongjiH
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
- ClinicalTrials.gov ID
- NCT06028165
- Acronym / sponsor ID
- MyongjiH
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Myongji HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Sep 2023 (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 aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes between the 2 groups.
Detailed description
The CABG-COREA trial is designed as a randomized, controlled trial to recruit 96 patients who undergo coronary artery bypass grafting. Patients were randomized by use of a randomization table. Coronary arteries are revascularized based on conventional coronary angiography (quantitative coronary angiography) or cardiac computed tomography-derived fractional flow reserve according to the randomization result.
The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAG group | Active comparator | Procedure: Coronary artery bypass grafting based on conventional coronary angiographyPatients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography) |
| CT-FFR group | Active comparator | Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age equal or more than 40
- age equal or less than 80
- patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
- patients who agree to the enrollment
Key exclusion criteria (9 listed)
- Patients with heart failure (left ventricular ejection fraction < 25%)
- patients who have intractable ventricular arrhythmia
- patients who has been treated for cancer
- patients who has infectious disease
- patients who are planned to undergo combined cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass grafting based on conventional coronary angiographyRevascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography) | Procedure or surgery | CAG group |
| Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve. | Procedure or surgery | CT-FFR group |
Primary outcome
1-Year graft patency rates
Time frame: 1 year
postoperative graft patency measured by 1 year postoperative coronary angiography
4 secondary outcomes
Overall survival
Time frame: 4 years
Freedom from Cardiac Death
Time frame: 4 years
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
Time frame: 4 years
Early Angiographic Patency Rates
Time frame: 1.5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD 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.
Min-Seok Kim, MD, PhD, MSc study chair
Cardiovascular Center, Myongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass grafting based on conventional coronary angiography and Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve. in people with Coronary Artery Disease, run by Myongji 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Seok Kim, MD, PhD, MSc (82-10-8482-0380, minseok.kim.md.phd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year graft patency rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024.