Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT04375306
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2020-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International prospective randomized multicenter superiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Cut-off value for the RFR that best predicts graft occlusion', 'timeFrame': 'Baseline'}, {'measure': 'Number of participants with graft dysfunction at 3 months post CABG', 'timeFrame': '3 months'}, {'measure': 'Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year', 'timeFrame': '1 year'}, {'measure': 'Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years', 'timeFrame': '3 years'}, {'measure': 'CD-TVR at 3 months post CABG', 'timeFrame': '1 year'}, {'measure': 'CD-TVR at 1 year post CABG', 'timeFrame': '1 year'}, {'measure': 'CD-TVR at 3 years post CABG', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RFR guided CABG', 'angiography guided CABG', 'Graft dysfunction'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI).\n\nIt 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.\n\nResting 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between 18 or older undergoing CABG\n* Patients willing and capable to provide written informed consent\n\nExclusion Criteria:\n\n* Previous CABG\n* Concomitant severe valvular disease intervention\n* Remaining (expected) coronary stenosis of \\> 50% diameter stenosis distally to graft anastomosis\n* Left ventricular ejection fraction \\<30%\n* Known transmural myocardial infarction\n* Documented microvascular disease\n* RFR/FFR measurement judged impossible\n* Life expectancy \\<2 years\n* Participation in other investigational clinical trials'}, 'identificationModule': {'nctId': 'NCT04375306', 'acronym': 'RFR-CABG', 'briefTitle': 'Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)', 'organization': {'class': 'OTHER', 'fullName': 'Diagram B.V.'}, 'officialTitle': 'Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial', 'orgStudyIdInfo': {'id': '9333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'angiography guided CABG', 'description': 'angiography guided CABG', 'interventionNames': ['Procedure: Angio guided CABG']}, {'type': 'EXPERIMENTAL', 'label': 'RFR guided CABG', 'description': 'RFR guided CABG', 'interventionNames': ['Procedure: RFR guided CABG']}], 'interventions': [{'name': 'RFR guided CABG', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['RFR guided CABG']}, {'name': 'Angio guided CABG', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['angiography guided CABG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonheiden', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dr. Dewilde, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Imelda ziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Bruges', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Belgium', 'facility': 'AZ Sint-Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Pawel Gasior, MD', 'role': 'CONTACT'}], 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Banská Bystrica', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Martin Hudec, MD, PhD', 'role': 'CONTACT'}], 'facility': 'SUSCCH', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}], 'centralContacts': [{'name': 'Prof. E. Kedhi, MD, PhD', 'role': 'CONTACT', 'email': 'ekedhi@me.com', 'phone': '+31 384262999'}, {'name': 'S. Postma, PhD', 'role': 'CONTACT', 'email': 'rfrcabg.trial@diagram-zwolle.nl', 'phone': '+31 384262999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This has not been decided yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diagram B.V.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}