The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients

Study Overview
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Brief Summary
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The purpose of this prospective cohort study is to investigate whether antithrombotic therapy in the secondary prevention of ischemic stroke increases the risk of the emerging CMBs and whether the change is associated with an increased risk of intracranial hemorrhage, providing an imaging evidence for individualized antithrombotic therapy in such patients.

Detailed Description
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Cerebral microbleeds（CMBs） is a subclinical lesion caused by microvascular disease in the brain, characterized by microleakage of blood. About 30% of ischemic stroke patients, 40% of the healthy people over 80 years old, and 60% of intracranial hemorrhage patients have microbleeds. With the development of imaging technology, clinically more and more patients have found microbleeds in the brain. How these patients are treated with antithrombotic drugs is not yet clear and is in urgent need of evidence. There are only a few prospective cohort studies to determine whether antithrombotic therapy increases the risk of intracranial hemorrhage in ischemic stroke patients with CMBs, but the results are uncertain. More importantly, whether antithrombotic therapy increases the incidence of the emerging CMBs, and whether the change of increased microbleeds is associated with increased intracranial hemorrhage has not been reported.

Official Title
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The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: SWI sequence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age ≥18 years; Acute ischemic stroke patient confirmed by imaging; Time of onset: within 3 months; Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke; Baseline SWI sequence must have at least one CMB ; NIHSS≤10 Exclusion Criteria: MRI contraindication; Hemorrhagic transformation after acute Ischemic stroke; Contraindication for antiplatelet or anticoagulation therapy; Severe head trauma or intracranial hemorrhage occurred in the past six months; obvious coagulopathy; Other intracranial lesions associated with (such as tumor, cerebral vascular malformation); other unqualified patients judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute ischemic stroke patient<br>acute ischemic stroke patient acute ischemic stroke patient Patient age ≥18 years .Acute ischemic stroke patient confirmed by imaging(SWI sequence) .Time of onset: within 3 months | Other: SWI sequence<br>* Acute ischemic stroke patient confirmed by SWI sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cerebral bleeding events | incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI | 360 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cerebral bleeding events | incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI | 180 days | 
| proportion of mRS 0-1. | the minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome | 180、360 days | 
| proportion of cerebral microbleeds | cerebral microbleeds, determined by MRI | 180 、360 days | 
| proportion of cerebral hemorrhage | cerebral hemorrhage, determined by MRI | 180、360 days | 
| the occurence of stroke or other vascular events |  | 180、360 days | 
| the occurence of death due to any cause |  | 180、360 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Hemorrhage, anti-thrombosis