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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| angiography guided CABG | Active Comparator | angiography guided CABG |
|
| RFR guided CABG | Experimental | RFR guided CABG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFR guided CABG | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cut-off value for the RFR that best predicts graft occlusion | Baseline | |
| Number of participants with graft dysfunction at 3 months post CABG | 3 months | |
| Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. E. Kedhi, MD, PhD | Contact | +31 384262999 | ekedhi@me.com | |
| S. Postma, PhD | Contact | +31 384262999 | rfrcabg.trial@diagram-zwolle.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda ziekenhuis | Recruiting | Bonheiden | Belgium |
This has not been decided yet.
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International prospective randomized multicenter superiority trial
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All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients in both arms. In the control arm (angiography guided CABG) the RFR values will be blinded to the cardiothoracic surgeon.
| Angio guided CABG | Procedure | 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. |
|
| 1 year |
| Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years | 3 years |
| CD-TVR at 3 months post CABG | 1 year |
| CD-TVR at 1 year post CABG | 1 year |
| CD-TVR at 3 years post CABG | 3 years |
| AZ Sint-Jan Brugge | Active, not recruiting | Bruges | Belgium |
| Medical University of Silesia | Recruiting | Katowice | Poland |
|
| SUSCCH | Recruiting | Banská Bystrica | Slovakia |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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