Comparing RFR and angiography for guiding heart surgery
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial
This study is testing if using a new method called Resting Full-cycle Flow Ratio can help doctors make better decisions during heart surgery compared to the traditional angiography method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Diagram B.V. Academic / other |
| Locations | 4 sites (Bonheiden and 3 other locations) |
| Trial ID | NCT04375306 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using Resting Full-cycle Flow Ratio (RFR) compared to traditional angiography in guiding revascularization strategies for patients undergoing coronary artery bypass grafting (CABG). The aim is to determine if RFR, which measures coronary stenosis at rest, can better predict graft failure and improve outcomes compared to angiography, which assesses blood flow during maximal stress. By analyzing the hemodynamic severity of coronary blockages, the study seeks to enhance surgical decision-making and patient outcomes in CABG procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for CABG and can provide informed consent.
Not a fit: Patients with previous CABG, severe valvular disease, or significant coronary stenosis distal to graft sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved graft success rates and better overall outcomes for patients undergoing CABG.
How similar studies have performed: Previous studies have shown that fractional flow reserve can effectively guide revascularization in percutaneous interventions, suggesting potential for success with RFR in surgical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bonheiden and 3 other locations
- Imelda ziekenhuis — Bonheiden, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Bruges, Belgium (Active_not_recruiting)
- Medical University of Silesia — Katowice, Poland (Recruiting)
- Suscch — Banská Bystrica, Slovakia (Recruiting)
Study contacts
- Study coordinator: Prof. E. Kedhi, MD, PhD
- Email: ekedhi@me.com
- Phone: +31 384262999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.