Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-27 @ 11:09 AM
Study NCT ID:
NCT05598632
Status:
RECRUITING
Last Update Posted:
2024-11-06
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Stroke and Systemic Embolic Events (SEE)', 'timeFrame': 'At 12-month after recruiting', 'description': 'The composite of stroke and Systemic Embolic Events (SEE) during follow-up. A stroke is defined as an abrupt onset, over minutes to hours, of a focal neurologic deficit that is generally in the distribution of a single brain artery (including the retinal artery) and that is not due to an identifiable nonvascular cause (ie, brain tumor or trauma).\n\nA systemic embolic event is defined as an abrupt episode of arterial insufficiency associated with clinical or radiologic evidence of arterial occlusion in the absence of other likely mechanisms (eg, atherosclerosis, instrumentation). Arterial embolic events involving the central nervous system (including the eye), coronary, and pulmonary arterial circulation are not considered SEEs,. Diagnosis of embolism to the lower extremities requires arteriographic demonstration of abrupt arterial occlusion.'}], 'secondaryOutcomes': [{'measure': 'Major Bleeding Events', 'timeFrame': 'At 12-month after recruiting', 'description': 'A major bleeding event is defined as clinically overt bleeding event (ie, bleeding that is visualized by examination or radiologic imaging) that meets ≥1 of the following:\n\n1. Fatal bleeding\n2. Symptomatic bleeding in a critical area or organ such as:\n\n * Retroperitoneal\n * Intracranial\n * Intraocular\n * Intraspinal\n * Intraarticular\n * Pericardial\n * Intramuscular with compartment syndrome'}, {'measure': 'All-Cause Mortality', 'timeFrame': 'At 12-month after recruiting', 'description': 'All-Cause Mortality during follow-up'}, {'measure': 'Cardiac Death', 'timeFrame': 'At 12-month after recruiting', 'description': 'Cardiac Death during follow-up'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': 'At 12-month after recruiting', 'description': 'Hospitalization for heart failure during follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Atrial fibrillation', 'Risk factors', 'Registry'], 'conditions': ['Atrial Fibrillation', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '41193204', 'type': 'DERIVED', 'citation': 'Qi W, Yuan S, Liu H, Xu M, Yang Y, Peng X, Hu Z, Zhang Y, Zhao Y, Zheng L, Yao Y, Zheng Z; Investigators the REFINE Registry; investors. Rationale, design and protocol for risk factors for stroke in patients with non-valvular atrial fibrillation in China: a nationwide registry (REFINE registry). BMJ Open. 2025 Nov 4;15(11):e104806. doi: 10.1136/bmjopen-2025-104806.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to validate the existing stroke risk stratification model for patients with atrial fibrillation (AF) (CHA2DS2-VASc Score, CHADS2 Score, ATRIA score, ABC score, etc.) and establish a new stroke risk assessment model using a nationwide AF -specific registry in China.', 'detailedDescription': 'This study is a multicenter prospective disease-specific registry of patients with atrial fibrillation (AF) that will analyze factors that are associated with stroke or systemic embolic events in patients with AF in China. Approximately 5,000 prospective cohort of patients and 22,000 retrospective cohort of patients will be enrolled. Consecutive patients who meet the eligibility criteria and provide informed consent. Patients enrolled in the registry will be followed for approximately 3 years. Patient follow-up by National Center for Cardiovascular Diseases will continue as scheduled. Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors, diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs. rhythm), antithrombotic therapy, concomitant medications and doses, laboratory tests, echo and computed tomography results, blood sample, insurance and provider information, comorbidities, and outcomes. The primary outcome will be stroke or non-CNS embolism. Other pre-defined outcomes of interest will include major adverse cardiac events, all-cause mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding, and hospitalization for heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Atrial fibrillation patients without valvular heart disease, prevous/planned ablation or left atrial appendage closure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older; male or female.\n* History of documented atrial fibrillation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects with moderate or severe mitral stenosis or a mechanical heart valve\n* Subjects with previous or planned AF ablation.\n* Subjects with previous or planned left atrial appendage closure.\n* Subjects unable to cooperate with follow-up after assessment.'}, 'identificationModule': {'nctId': 'NCT05598632', 'briefTitle': 'Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Risk Factors for Stroke or Systemic Embolism in Chinese Patients with Non-Valvular Atrial Fibrillation Registry', 'orgStudyIdInfo': {'id': '2021-CXGC09-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '100027', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Yao, MD, PhD', 'role': 'CONTACT', 'email': 'ianyao@263.net', 'phone': '+86 187 0101 3797'}], 'facility': 'Fuwai Hospital, CAMS & PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhe Zheng, MD, PhD', 'role': 'CONTACT', 'email': 'zhengzhe@fuwai.com', 'phone': '+86-010-88396051'}, {'name': 'Shuo Yuan, MD', 'role': 'CONTACT', 'email': 'yuanshuo@fuwai.com'}], 'overallOfficials': [{'name': 'Zhe Zheng, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Hospital, Chinese Academy of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}