Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-30 @ 9:54 AM
Study NCT ID:
NCT06822894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 495}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE) at 1 year', 'timeFrame': '1 year after the procedure', 'description': 'The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization.'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE) at 1 month', 'timeFrame': '1 month after the procedure', 'description': 'MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.'}, {'measure': 'Major adverse cardiac events (MACE) at 6 months', 'timeFrame': '6 months after the procedure', 'description': 'MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease (CAD)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant three coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of at least 495 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of all the three coronary artery stenoses will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or older admitted to Fuwai Hospital (Beijing, China) for coronary angiography and demonstrating angiographically confirmed ≥30% stenosis in all three major coronary arteries through visual assessment, will be consecutively enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction; Age ≥18 years; Written informed consent; Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery); Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment.\n\nExclusion Criteria:\n\nIneligible for diagnostic IVUS examination; Prior coronary artery bypass grafting (CABG); Myocardial infarction within 72 hours of coronary angiography; Severe heart failure; Serum creatinine levels \\>150 umol/L, or glomerular filtration rates \\<45 ml/ kg/1.73 m2; Allergy to the contrast agent or adenosine; Life expectancy \\< 2 years; Severe coronary artery disease requiring CABG identified during angiography; Extreme vascular tortuosity precluding IVUS catheter advancement; Suboptimal IVUS image quality impairing quantitative analysis.'}, 'identificationModule': {'nctId': 'NCT06822894', 'acronym': 'FUNCTION III', 'briefTitle': 'Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2024-2-4034'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Qian, MD', 'role': 'CONTACT', 'email': 'qianjfw@163.com', 'phone': '+8613601396650'}, {'name': 'Cheng Yang, MD', 'role': 'CONTACT', 'email': 'yangcheng_fw@163.com', 'phone': '+8619801116690'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}