Coronary Artery DiseaseRFR-CABGNCT04375306
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
A study testing RFR guided CABG and Angio guided CABG in people with Coronary Artery Disease, run by Diagram B.V. at 4 sites in 3 countries.
Trial summary
Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI). It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- RFR guided CABG and Angio guided CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 3 Feb 2020to 30 Jun 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients between 18 or older undergoing CABG
- Patients willing and capable to provide written informed consent
Who cannot join
- Previous CABG
- Concomitant severe valvular disease intervention
- Remaining (expected) coronary stenosis of > 50% diameter stenosis distally to graft anastomosis
- Left ventricular ejection fraction <30%
- Known transmural myocardial infarction
- Documented microvascular disease
Show all 9Show fewer
- RFR/FFR measurement judged impossible
- Life expectancy <2 years
- Participation in other investigational clinical trials
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Belgium2 sites, 1 recruiting
- Recruiting
Imelda ziekenhuis
Bonheiden
Dr. Dewilde, MD, PhD
- Active, not recruiting
AZ Sint-Jan Brugge
Bruges
Poland1 site, 1 recruiting
- Recruiting
Medical University of Silesia
Katowice
Pawel Gasior, MD
Slovakia1 site, 1 recruiting
- Recruiting
SUSCCH
Banská Bystrica
Martin Hudec, MD, PhD
About this study
Official title: Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial
Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI).
It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow.
Resting full-cycle Flow Ratio (RFR) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. Differently from FFR which is a measurement performed in maximal hyperemia, the RFR is a measurement that is performed in rest and therefore may predict better than FFR the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as FFR. It is unknown whether RFR guided CABG revascularization is superior as compared to angiography alone.
- Conditions
- Coronary Artery Disease
- Being tested
- RFR guided CABG, Angio guided CABG
- Keywords
- RFR guided CABG, angiography guided CABG, Graft dysfunction
- 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.
RFR guided CABGProcedure or surgery
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the experimental arm the decision to revascularize will be based on RFR.
Angio guided CABGProcedure or surgery
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the control arm the RFR values will be blinded to the cardiothoracic surgeon.
| Study group | Role | What they receive |
|---|---|---|
| angiography guided CABG | Active comparator | angiography guided CABG Receives: Procedure: Angio guided CABG |
| RFR guided CABG | Experimental | RFR guided CABG Receives: Procedure: RFR guided CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who deceased, had a Myocardial Infarction (MI), Clinically-Driven Target Vessel Revascularization (CD-TVR), Stroke or Graft Dysfunction at 3 months post CABG
Measured: 3 months
Secondary outcomes (7)
Cut-off value for the RFR that best predicts graft occlusion
Measured: Baseline
Number of participants with graft dysfunction at 3 months post CABG
Measured: 3 months
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year
Measured: 1 year
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years
Measured: 3 years
CD-TVR at 3 months post CABG
Measured: 1 year
CD-TVR at 1 year post CABG
Measured: 1 year
CD-TVR at 3 years post CABG
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start3 Feb 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Jun 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International prospective randomized multicenter superiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375306
- Sponsor's protocol ID
- 9333
- Acronym
- RFR-CABG
- Status last verified
- Jan 2024
- First submitted
- 1 May 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This has not been decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial
- ClinicalTrials.gov ID
- NCT04375306
- Acronym / sponsor ID
- RFR-CABG / 9333
- Conditions
- Coronary Artery Disease
- Keywords
- RFR guided CABG, angiography guided CABG, Graft dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 May 2020 (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.
Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI).
It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow.
Resting full-cycle Flow Ratio (RFR) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. Differently from FFR which is a measurement performed in maximal hyperemia, the RFR is a measurement that is performed in rest and therefore may predict better than FFR the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as FFR. It is unknown whether RFR guided CABG revascularization is superior as compared to angiography alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- International prospective randomized multicenter superiority trial
| Arm | Type | Receives |
|---|---|---|
| angiography guided CABG | Active comparator | Procedure: Angio guided CABGangiography guided CABG |
| RFR guided CABG | Experimental | Procedure: RFR guided CABGRFR guided CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients between 18 or older undergoing CABG
- Patients willing and capable to provide written informed consent
Key exclusion criteria (9 listed)
- Previous CABG
- Concomitant severe valvular disease intervention
- Remaining (expected) coronary stenosis of > 50% diameter stenosis distally to graft anastomosis
- Left ventricular ejection fraction <30%
- Known transmural myocardial infarction
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 |
|---|---|---|
| RFR guided CABGAll patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the experimental arm the decision to revascularize will be based on RFR. | Procedure or surgery | RFR guided CABG |
| Angio guided CABGAll patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the control arm the RFR values will be blinded to the cardiothoracic surgeon. | Procedure or surgery | angiography guided CABG |
Primary outcome
Number of participants who deceased, had a Myocardial Infarction (MI), Clinically-Driven Target Vessel Revascularization (CD-TVR), Stroke or Graft Dysfunction at 3 months post CABG
Time frame: 3 months
7 secondary outcomes
Cut-off value for the RFR that best predicts graft occlusion
Time frame: Baseline
Number of participants with graft dysfunction at 3 months post CABG
Time frame: 3 months
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year
Time frame: 1 year
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years
Time frame: 3 years
CD-TVR at 3 months post CABG
Time frame: 1 year
CD-TVR at 1 year post CABG
Time frame: 1 year
CD-TVR at 3 years post CABG
Time frame: 3 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 1 Feb 2024.
- Individual participant dataSharing planned: Undecided. This has not been decided yet.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFR guided CABG and Angio guided CABG in people with Coronary Artery Disease, run by Diagram B.V. at 4 sites in 3 countries.
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 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: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Poland, Slovakia. 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?
Contact Prof. E. Kedhi, MD, PhD (+31 384262999, ekedhi@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who deceased, had a Myocardial Infarction (MI), Clinically-Driven Target Vessel Revascularization (CD-TVR), Stroke or Graft Dysfunction at 3 months post CABG (time frame: 3 months). 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 1 Feb 2024.