Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 1:12 AM
Study NCT ID:
NCT04814550
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2020-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
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': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard', 'timeFrame': '7 days', 'description': 'Hemodynamically significant coronary artery stenosis: FFR≤0.8'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard', 'timeFrame': '7 days', 'description': 'Hemodynamically significant coronary artery stenosis: FFR≤0.8'}, {'measure': 'AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis', 'timeFrame': '7 days', 'description': 'Hemodynamically significant coronary artery stenosis: FFR≤0.8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39719423', 'type': 'DERIVED', 'citation': 'Jiang J, Hu Y, Li C, Dong L, Xu J, Tang L, Jiang W, Du C, Jiang X, Lyu Y, Leng X, Li C, Koo BK, Xiang J, Ge J, Wang J. Diagnostic Accuracy of Computational Fluid Dynamics-Based Fractional Flow Reserve Derived From Coronary Angiography: The ACCURATE Study. J Am Heart Assoc. 2025 Jan 7;14(1):e035672. doi: 10.1161/JAHA.124.035672. Epub 2024 Dec 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable angina, unstable angina or myocardial infarction after the acute phase', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years;\n* Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Subjects judged unsuitable for diagnostic intervention or FFR;\n* Myocardial infarction within 6 days;\n* LVEF ≤50%;\n* eGFR \\<60ml/min（1.73m²）\n* Severe coagulation dysfunction or bleeding disorders;\n* Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;\n* Participated in other clinical trials within 1 months;\n* Other situations that were not suitable for inclusion, as judged by investigators.'}, 'identificationModule': {'nctId': 'NCT04814550', 'acronym': 'ACCURATE', 'briefTitle': 'Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2020-153'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FFR', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['AccuFFRangio'], 'description': 'FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}