The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SWI sequence.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study
Overview
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
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.
Interventions
- Other SWI sequence
Acute ischemic stroke patient confirmed by SWI sequence
Primary outcome measures
- all cerebral bleeding events [Time frame: 360 days]
Secondary outcome measures (6)
- all cerebral bleeding events [Time frame: 180 days]
- proportion of mRS 0-1. [Time frame: 180、360 days]
- proportion of cerebral microbleeds [Time frame: 180 、360 days]
- proportion of cerebral hemorrhage [Time frame: 180、360 days]
- the occurence of stroke or other vascular events [Time frame: 180、360 days]
- the occurence of death due to any cause [Time frame: 180、360 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- General Hospital of ShenYang Military Region — Shenyang
Identifiers
NCT: NCT03571763 · k(2017)33