Stroke Clinical Trial
Official title:
Microbleeds and Genetic Risk Factors to Predict the Risk of Intracranial Haemorrhage in Patients Treated With Anticoagulation Following Cardioembolic Stroke Due to Atrial Fibrillation
Study I: CROMIS-2 (AF) Prospective cohort study of patients anticoagulated after
cardioembolic stroke An observational inception cohort study (n=1425) of patients throughout
the United Kingdom (UK) - (79 hospitals) started on best practice oral anticoagulant (without
prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up
for the occurrence of intracerebral haemorrhage (ICH) and ischaemic stroke for an average of
two years. The main baseline exposures (risk factors of interest) are the presence of
cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI), and genetic polymorphisms in
candidate genes with potential functional relevance to ICH risk.
Study II: CROMIS-2 (ICH) Observational and genetics study of intracerebral haemorrhage The
investigators will also recruit 600 patients admitted to participating centres with ICH (with
a target of at least 300 anticoagulant-related ICH cases) and collect DNA to increase the
power of the genetic studies. The investigators will collect clinical and imaging data from
these ICH cases to investigate risk factors associated with anticoagulant-related ICH
compared to non anticoagulant-related ICH.
Background Over the last decade, increasing use of oral anticoagulants to prevent
cardioembolic ischaemic stroke due to atrial fibrillation (AF) in an ageing population has
led to a five-fold increase in the incidence of anticoagulant-related intracranial
haemorrhage (ICH) - a rare but unpredictable and catastrophic complication. Cerebral
microbleeds (CMBs) on magnetic resonance imaging (MRI) may predict ICH risk, as may genetic
polymorphisms influencing brain small-vessel integrity or anticoagulation stability.
Aims To establish the value of CMBs and genetic factors in predicting symptomatic ICH
following best practice oral anticoagulation to prevent recurrent ischaemic stroke due to AF.
Methods CROMIS-2: Study I (AF) - Prospective, multicentre, inception cohort study in 1425
patients with ischaemic stroke due to AF started on best practice oral anticoagulation.
Patients will have genetic testing and standardized MRI including Gradient recalled Echo
(GRE) at baseline, with follow-up by postal questionnaire (and clinical assessment or medical
records surveillance after suspected events), and where possible there will be an in person
clinical assessment at 2 years. The investigators will compare the rate of symptomatic ICH
between CMB and CMB-free patients and test for associations with plausible candidate genes.
The investigators aim to develop and validate a risk model to predict symptomatic ICH
following best practice oral anticoagulation to prevent recurrent ischaemic stroke due to AF.
CROMIS-2: Study II (ICH) - An observational study of ICH investigating genetic, clinical and
radiological risk factors associated with anticoagulant-related ICH. The investigators will
recruit patients admitted to participating centres with ICH (with a target of at least 300
anticoagulant-related ICH cases) and collect DNA to increase the power of the genetic
studies. The investigators will collect clinical and imaging data from these ICH cases to
investigate risk factors associated with anticoagulant-related ICH compared to non
anticoagulant-related ICH.
Expected outcomes A successful predictive model for ICH risk after best practice oral
anticoagulation for AF will help to determine whether genetic or CMB screening should be used
in clinical practice and future trials. New genetic, clinical and radiological risk factors
associated with anticoagulant-related ICH will be identified.
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