Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 1:16 PM
Study NCT ID:
NCT05209503
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2022-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Implications of AccuFFRangio-guided PCI in STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], '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'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vessel-oriented composite endpoints (VOCEs)', 'timeFrame': '1 year', 'description': 'Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.'}, {'measure': 'Post-PCI AccuFFRangio', 'timeFrame': '1 year', 'description': 'AccuFFRangio limits to yield no VOCEs (Composite of vessel-related cardiovascular death, vessel-related myocardial).'}], 'secondaryOutcomes': [{'measure': 'Cost analysis', 'timeFrame': '1 year', 'description': 'Cost savings of AccuFFRangio-guided strategy. Evaluation of costs by excess/reduced need for PCI when AccuFFRangio and Angiography disagree.'}, {'measure': 'Prognostic implications', 'timeFrame': '1 year', 'description': 'The time from randomization to first occurrence of any of composite outcome including vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years and older\n* STEMI patients with primary percutaneous coronary intervention within 24 hours with at least 1 non-IRA\n* Diameter stenosis of 50%-90% by visual estimate\n* Reference vessel size \\> 2 mm in stenotic segment by visual estimate\n\nExclusion Criteria:\n\n* LVEF ≤ 40%\n* eGFR \\< 60 mL/min\n* Allergy to contrast media, adenosine\n* Prior CABG'}, 'identificationModule': {'nctId': 'NCT05209503', 'briefTitle': 'Prognostic Implications of AccuFFRangio-guided PCI in STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'Prognostic Implications of AccuFFRangio-based Functional Evaluation for Guiding Coronary Intervention for Non-IRA Stenosis in Patients With STEMI', 'orgStudyIdInfo': {'id': 'AFCA20220105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AccuFFRangio Group', 'description': 'STEMI patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography. First, the revascularization of the criminal vessel (PCI) was completed. The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good. The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8.', 'interventionNames': ['Other: AccuFFRangio-guided strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angiography Group', 'description': 'The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis \\> 70% based on angiographic results.', 'interventionNames': ['Other: Angiography-guided strategy']}], 'interventions': [{'name': 'AccuFFRangio-guided strategy', 'type': 'OTHER', 'description': 'In this study, the AccuFFRangio-guided strategy will be applied to in the AccuFFRangio group in which calculation of the AccuFFRangio values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to PCI revascularization will be carried out. If AccuFFRangio ≤ 0.80, then simultaneous PCI revascularization of target blood vessels will be carried out. If AccuFFRangio \\> 0.80, then no PCI revascularization of target blood vessels will be carried out.', 'armGroupLabels': ['AccuFFRangio Group']}, {'name': 'Angiography-guided strategy', 'type': 'OTHER', 'description': 'In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 70% (visual estimation) and suited for PCI revascularization will undergo PCI revascularization.', 'armGroupLabels': ['Angiography Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dan Song, MD', 'role': 'CONTACT', 'email': 'songdan8300@163.com', 'phone': '+86-027-65796888'}], 'overallOfficials': [{'name': 'Dan Song, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wuhan Aisa Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}