Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RFR guided CABG, Angio guided CABG.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Poland, Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Procedure RFR guided CABG
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. - Procedure Angio guided CABG
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.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- All patients between 18 or older undergoing CABG
- Patients willing and capable to provide written informed consent
Exclusion criteria
- 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
- RFR/FFR measurement judged impossible
- Life expectancy <2 years
- Participation in other investigational clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- Imelda ziekenhuis — Bonheiden
- AZ Sint-Jan Brugge — Bruges
Poland · 1 center
- Medical University of Silesia — Katowice
Slovakia · 1 center
- SUSCCH — Banská Bystrica
Identifiers
NCT: NCT04375306 · 9333