Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-17 @ 10:12 PM
Study NCT ID:
NCT03788512
Status:
RECRUITING
Last Update Posted:
2022-01-11
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}], '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': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'anticoagulant peripheral blood, serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2018-12-25', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Major Adverse Cardiovascular Events', 'timeFrame': '1 year', 'description': 'cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina'}], 'secondaryOutcomes': [{'measure': 'Rate of Major Adverse Cardiovascular Events', 'timeFrame': '90 days', 'description': 'cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina'}, {'measure': 'Functional Outcome', 'timeFrame': '90 days', 'description': 'Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.'}, {'measure': 'Rate of Ischemic Stroke', 'timeFrame': '1 year', 'description': 'fatal and nonfatal ischemic stroke.'}, {'measure': 'Rate of Acute Coronary Syndrome', 'timeFrame': '1 year', 'description': 'fatal and nonfatal myocardial infarction and unstable angina'}, {'measure': 'Rate of Cardiovascular Mortality', 'timeFrame': '1 year', 'description': 'any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death'}, {'measure': 'Time to First Major Adverse Cardiovascular Event', 'timeFrame': '5 years', 'description': 'from the date of enrollment until the date of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina, whichever comes first, assessed up to 5 years'}, {'measure': 'Time to First Ischemic Stroke', 'timeFrame': '5 years', 'description': 'from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years'}, {'measure': 'Rate of Major Adverse Cardiovascular Events', 'timeFrame': '5 years', 'description': 'cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina'}, {'measure': 'Rate of Ischemic Stroke', 'timeFrame': '5 years', 'description': 'fatal and nonfatal ischemic stroke'}, {'measure': 'Rate of Acute Coronary Syndrome', 'timeFrame': '5 years', 'description': 'fatal and nonfatal myocardial infarction and unstable angina'}, {'measure': 'Rate of Cardiovascular Mortality', 'timeFrame': '5 years', 'description': 'any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute ischemic cerebrovascular disease', 'cerebral atherosclerosis', 'coronary atherosclerosis', 'coexistence'], 'conditions': ['Coexistence of Cerebral and Coronary Atherosclerosis', 'Acute Ischemic Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center observational registry of patients hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes in both cerebral and coronary arteries.\n\nThis registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.', 'detailedDescription': "Atherosclerosis has exerted huge global burden as the common pathological process underlying ischemic heart disease and cerebrovascular disease. A substantial portion of acute ischemic cerebrovascular disease (AICVD) patients have both cerebral and coronary atherosclerosis, which is an omen of poor outcomes. But there is large evidence gap in these high-risk patients' prognosis-related factors, limiting the improvement of care quality.\n\nCoexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center prospective observational registry of patients hospitalized for AICVD with atherosclerotic changes in both cerebral and coronary arteries.\n\nThis registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.\n\nThe clinical, imaging and laboratory information will be collected at the baseline. During an estimated 5-year follow-up, the vessel-related diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as ischemic stroke or transient ischemic attack (TIA).\n2. Less than 30 days after onset of ischemic stroke or TIA symptoms.\n3. Extracranial or intracranial cerebral atherosclerosis confirmed by vascular ultrasound or CT angiograpgy or MR angiograpgy or digital substraction angiography.\n4. Coronary atherosclerosis confirmed by CT angiograpgy or MR angiograpgy or digital substraction angiography; or with myocardial ischemia symptoms confirmed using electrocardiogram or echocardiography or cardiac MR; or with a history of percutaneous coronary intervention or coronary artery bypass graft.\n\nExclusion Criteria:\n\n1. With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 5 years.\n2. Patients refuse to participate in the research.'}, 'identificationModule': {'nctId': 'NCT03788512', 'acronym': 'CoCCA', 'briefTitle': 'Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry', 'orgStudyIdInfo': {'id': 'CoCCA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AICVD patients with CoCCA', 'description': 'acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis.', 'interventionNames': ['Other: observational only- no intervention']}], 'interventions': [{'name': 'observational only- no intervention', 'type': 'OTHER', 'description': 'observational only- no intervention', 'armGroupLabels': ['AICVD patients with CoCCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'BJ', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Ma, MD, PhD', 'role': 'CONTACT', 'email': 'maxin118@hotmail.com', 'phone': '13501390691'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xin Ma, MD, PhD', 'role': 'CONTACT', 'email': 'maxin118@hotmail.com', 'phone': '13501390691'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Xin Ma', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}