Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT07034157
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], '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': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-06-15', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Head and Neck Artery Stenosis in Patients with Coronary Artery Disease', 'timeFrame': 'At baseline (prior to or during initial hospitalization)', 'description': 'The proportion of patients with coronary artery disease who are found to have head and neck artery (e.g., carotid or vertebral artery) stenosis, as determined by duplex ultrasound or other imaging modalities.'}], 'secondaryOutcomes': [{'measure': 'mRS score', 'timeFrame': '7±1 days or the day discharged'}, {'measure': 'mRS Score', 'timeFrame': '90±7 days'}, {'measure': 'mRS Score', 'timeFrame': '365±30 days'}, {'measure': 'Rate of cardiovascular and cerebrovascular events', 'timeFrame': '90±7 days'}, {'measure': 'Rate of cardiovascular and cerebrovascular events', 'timeFrame': '365±30 days'}, {'measure': 'Short-term complications', 'timeFrame': '90±7 days'}, {'measure': 'Long-term complications', 'timeFrame': '365±30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Carotid Artery Stenosis', 'Doppler Ultrasound', 'Combined Vascular Intervention'], 'conditions': ['Coronary Artery Disease', 'Carotid Artery Stenosis', 'Cerebrovascular Disorders']}, 'descriptionModule': {'briefSummary': 'This prospective observational cohort study aims to investigate the prevalence and clinical significance of head and neck arterial stenosis in patients with coronary artery disease (CAD) undergoing or scheduled for percutaneous coronary intervention (PCI). Using Doppler ultrasound as the primary screening tool, the study will assess the degree of stenosis and evaluate the impact of different combined treatment strategies on patient outcomes. The research will provide real-world evidence to optimize integrated care approaches for patients with comorbid cardiovascular and cerebrovascular diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (aged ≥18 years) diagnosed with coronary artery stenosis who are scheduled for or have recently undergone percutaneous coronary intervention (PCI), and who will undergo ultrasound screening for concomitant head and neck arterial stenosis. Participants will be enrolled from a tertiary care hospital in China as part of a prospective observational cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.\n\nExclusion Criteria:\n\n1. The expected survival is less than 1 years;\n2. Simultaneously merge other serious diseases;'}, 'identificationModule': {'nctId': 'NCT07034157', 'acronym': 'ANGEL-UNIFY', 'briefTitle': 'A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis', 'orgStudyIdInfo': {'id': 'KS2025006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: PCI + Carotid Revascularization', 'description': 'Patients diagnosed with both coronary artery disease and significant carotid artery stenosis requiring intervention, who received both PCI and carotid revascularization.', 'interventionNames': ['Procedure: Percutaneous Coronary Intervention', 'Procedure: Cerebrovascular Intervention (CAS ）']}, {'label': 'Group 2: PCI + Observation of Carotid Stenosis', 'description': 'Patients who underwent PCI for coronary artery disease, with no carotid stenosis or with carotid stenosis not requiring or not receiving interventional treatment.', 'interventionNames': ['Procedure: Percutaneous Coronary Intervention', 'Other: No Intervention / Observation']}, {'label': 'Group 3: Observation Only (No PCI + No CAS)', 'description': 'Patients who did not undergo PCI and either had no carotid artery stenosis or were managed medically for carotid stenosis without any revascularization.', 'interventionNames': ['Other: No Intervention / Observation']}], 'interventions': [{'name': 'Percutaneous Coronary Intervention', 'type': 'PROCEDURE', 'description': 'Coronary stenting performed as part of routine care for patients with coronary artery stenosis.', 'armGroupLabels': ['Group 1: PCI + Carotid Revascularization', 'Group 2: PCI + Observation of Carotid Stenosis']}, {'name': 'Cerebrovascular Intervention (CAS ）', 'type': 'PROCEDURE', 'description': 'Patients with intervention-indicated head and neck artery stenosis will receive carotid artery stenting based on clinical evaluation.', 'armGroupLabels': ['Group 1: PCI + Carotid Revascularization']}, {'name': 'No Intervention / Observation', 'type': 'OTHER', 'description': 'Clinical observation or standard follow-up in patients without significant disease', 'armGroupLabels': ['Group 2: PCI + Observation of Carotid Stenosis', 'Group 3: Observation Only (No PCI + No CAS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Tong', 'role': 'CONTACT', 'email': 'Tomice123@foxmail.com', 'phone': '+86 1781065108'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaochuan Huo, M.D.', 'role': 'CONTACT', 'email': 'huoxiaochuan@126.com', 'phone': '+8613716292262'}, {'name': 'Xin Tong, M.D.', 'role': 'CONTACT', 'email': 'Tomice123@foxmail.com', 'phone': '+8617810651085'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Xiaochuan Huo', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}