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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• 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 [Срок оценки: 3 months]

Вторичные конечные точки (7)

• Cut-off value for the RFR that best predicts graft occlusion [Срок оценки: Baseline]
• Number of participants with graft dysfunction at 3 months post CABG [Срок оценки: 3 months]
• Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year [Срок оценки: 1 year]
• Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years [Срок оценки: 3 years]
• CD-TVR at 3 months post CABG [Срок оценки: 1 year]
• CD-TVR at 1 year post CABG [Срок оценки: 1 year]
• CD-TVR at 3 years post CABG [Срок оценки: 3 years]

Критерии участия

Критерии включения

• All patients between 18 or older undergoing CABG
• Patients willing and capable to provide written informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 2 центра

• Imelda ziekenhuis — Bonheiden
• AZ Sint-Jan Brugge — Bruges

Польша · 1 центр

• Medical University of Silesia — Katowice

Словакия · 1 центр

• SUSCCH — Banská Bystrica

Идентификаторы

NCT: NCT04375306 · 9333

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗