Multimodal Prognostic Assessment of AIS With AF
NCT Number: NCT06548269
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Ischemic Stroke|Atrial Fibrillation
Interventions: DIAGNOSTIC_TEST: Cardiologic work-up
Sponsor: Jinan Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-01-01
Completion Date: 2028-12-31
Locations: Jinan Central Hospital, Jinan, Shandong, 250013, China

Summary:
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC \[oral anticoagulation\], antiplatelet \[APT\]) and left atrial appendage closure \[LAAC\] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.

Primary Outcome Measures: Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality, Stroke including ischemic or hemorrhagic stroke, 1 year
Secondary Outcome Measures: Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality, Stroke including ischemic or hemorrhagic stroke, 3 years
Other Outcome Measures: Ischemic stroke, Rapid onset of a new focal neurological deficit with clinical and imaging evidence of infarction and not attributable to a non-ischemic etiology., 12, 36months|Hemorrhagic stroke, Hemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by a nontraumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage, 12, 36months|Systemic embolism, Systemic embolism was defined as an acute vascular occlusion of an extremity or organ confirmed by imaging or either surgery or autopsy., 12, 36months|Myocardial infarction (MI), Myocardial infarction will be assessed according to the third universal definition of myocardial infarction (Eur Heart J, 2012)., 12, 36months|BARC type 2 or 5 bleeding events, According to the BARC (Bleeding Academic Research Consortium) definition for bleeding, 12, 36months|All-cause mortality, The occurrence of death from any cause, 12, 36months|Changes in functional status based on Modified Rankin Scale, The Modified Rankin scale is used to measure the degree of disability or dependence in daily activities caused by a stroke. The scale runs from 0 to 6, from no symptoms (0) to death (6)., 12, 36months|Changes in Barthel Index, The Barthel Index for Activities of Daily Living is uesd to measure a person's ability to complete activities of daily living (ADL).The total score range from 0 to 100, with higher scores indicating greater independence., 12, 36months|Relationship between atrial fibrillation burden and recurrent ischemic stroke, The association between atrial fibrillation burden measured from 7-day single lead ECG recorders and recurrent ischemic stroke, 12, 36months|Proportion of patients receiving any types of secondary prevention therapies at 3, 6, 12, 24 and 36 months, Including APT, OAC, LAAC or the combination of both, 3, 6, 12, 24, 36 months