Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT06979427
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CTFFR and Prediction of Non-Significant CAD Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'NIFFR of coronary less than 0.8'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with MACE', 'timeFrame': '1 year', 'description': 'Number of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke'}, {'measure': 'Number of patients with bleeding', 'timeFrame': '1 year', 'description': 'Number of patients with major or minor bleeding based on BARC classification'}], 'secondaryOutcomes': [{'measure': 'Number of patients with dyspnoea', 'timeFrame': '1 year', 'description': 'Number of patients with minor and major dyspnoea ( based on that it affect daily activity or tolerable or not)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Coronary Syndrome', 'Major adverse coronary events (MACE)', 'fractional flow reserve', 'coronary CT angiography'], 'conditions': ['Chronic Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'In this prospective cohort study, 250 patients with suspected or known CAD and at least one intermediate coronary lesion (50-70% stenosis) who had a NiFFR value greater than 0.80 underwent coronary computed tomography angiography (CCTA) with NiFFR assessment. Patients were followed for one year to monitor for MACE', 'detailedDescription': 'This prospective cohort includes people with known or suspected CAD who had both CCTA and ICA with this index (FFR) measurements. Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing.\n\nData about the patients was acquired from the Professor Kojuri registry. The database provided demographic information for instance age, gender, CAD family history, prior CAD history, hypertension (HTN), diabetes mellitus (DM), and hyperlipidaemia (HLP). The prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics were also collected from registry.\n\nThe target vessel was identified (LAD, RCA, LCX, or LMC), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. Measurements were taken using CCTA datasets using semi-automated software methods.\n\nPatients were clinically monitored for one year after examination. The primary outcome was the occurrence of major cardiovascular consequences, or MACE, which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons. Throughout the one-year study period, all participants were visited every three months and followed up with phone calls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing\n\nExclusion Criteria:\n\n* Patients having past coronary artery bypass graft surgery (CABG)\n* previous PCI in the target vascular\n* significant renal impairment define with eGFR \\< 30 mL/min/1.73 m²\n* contrast allergy\n* poor image quality that prevented appropriate CCTA or CT-FFR analysis'}, 'identificationModule': {'nctId': 'NCT06979427', 'briefTitle': 'CTFFR and Prediction of Non-Significant CAD Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Evaluation of the Ability of CTFFR to Determine Non-significant Lesions of Coronary Disease Based on MACE in One-year Follow-up of Patients (Seeing Beyond the Stenosis: CTFFR and MACE in a One-Year Follow-Up)', 'orgStudyIdInfo': {'id': '1403.414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nonsignificant NIFFR', 'description': 'patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8', 'interventionNames': ['Diagnostic Test: NIFFR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'significant NIFFR', 'description': 'patients with coronary artery lesion in CT angiography, with NIFFR of more than 0.8', 'interventionNames': ['Diagnostic Test: NIFFR']}], 'interventions': [{'name': 'NIFFR', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Non invasive fractional flow reserve'], 'description': 'Fractional flow reserve derived from CT angiography from lesion between 50-70%', 'armGroupLabels': ['nonsignificant NIFFR', 'significant NIFFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55318', 'city': 'Shiraz', 'state': 'Fars', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'javad kojuri, MD.MS', 'role': 'CONTACT', 'email': 'kojurij@yahoo.com', 'phone': '09171115083'}, {'name': 'javad kojuri, MD.MS.', 'role': 'CONTACT', 'email': 'kojurij@yahoo.com', 'phone': '09171115083'}], 'facility': 'Professor Kojuri Cardiology Clinic', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'centralContacts': [{'name': 'javad UOM kojuri', 'role': 'CONTACT', 'email': 'kojurij@yahoo.com', 'phone': '09171115083'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data sharing by rational request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Javad Kojuri', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}