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NCT Number: NCT04375306

Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda ziekenhuis, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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 outcomes

  1. Cut-off value for the RFR that best predicts graft occlusion

    Time frame: Baseline

  2. Number of participants with graft dysfunction at 3 months post CABG

    Time frame: 3 months

  3. Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year

    Time frame: 1 year

  4. Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years

    Time frame: 3 years

  5. CD-TVR at 3 months post CABG

    Time frame: 1 year

  6. CD-TVR at 1 year post CABG

    Time frame: 1 year

  7. CD-TVR at 3 years post CABG

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. E. Kedhi, MD, PhD

CONTACT

[email protected]

+31 384262999

S. Postma, PhD

CONTACT

[email protected]

+31 384262999

Sponsors and collaborators

Lead sponsor

Diagram B.V.

Other

Registry information

Official study 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

Acronym: RFR-CABG

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
May 5, 2020
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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