Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke

Study Overview
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Brief Summary
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Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Currently, it is unknown what happens to those patients with remote hemorrhage beyond 3 months of follow-up in terms of risk/benefit balance when receiving antiplatelet or anticoagulant therapy, as well as from a cognitive point of view. Considering an analogy with amyloid angiopathy, the hypothesis is that those patients with remote hemorrhage have a higher risk of intracranial hemorrhage during follow-up when receiving stroke secondary prevention, and will also present greater cognitive deterioration during long-term follow-up. Main Objectives To explore the frequency and risk factors for intracranial hemorrhage during follow-up of patients with remote cerebral hemorrhage. To explore the frequency and progression of cognitive deterioration during follow-up in patients with remote cerebral hemorrhage. Methodology Observational, prospective, multicenter registry with a population-based case-control design of consecutive patients with remote hemorrhage following reperfusion therapy in acute ischemic stroke. Inclusion criteria: Diagnosis of ischemic stroke with age greater than or equal to 18 years who has remote cerebral hemorrhage after receiving reperfusion therapy in the acute phase. Exclusion criteria: Lack of basic data (age, sex, neuroimaging data) or telephone for follow-up. The cases will be those patients with remote hemorrhage. For each case included, 4 consecutive controls will be included (2 with local parenchymal hemorrhagic transformation and 2 without hemorrhagic transformation). The data will be filled out within the (Codi Ictus de CATalunya) CICAT registry form (currently mandatory in all stroke centers in Catalonia) to which additional variables will be added. Telephone follow-up will be conducted at 3, 12, and 24 months. Main study variable: Any type of spontaneous or traumatic intracranial hemorrhage during a 24-month follow-up. Score on the Short Informant Questionnaire scale (a validated 17-question questionnaire to be conducted over the phone, where a score higher than 57 points indicates cognitive impairment). Expected sample size during a 2-year recruitment period: 105-300 patients (considering the participating centers to date). Additional information. This study is endorsed by the Pla Director de la Malaltia Vascular Cerebral in Catalonia. Participating Centers. Participation offers have been sent to the 28 hospitals in the hospital network of Catalonia with the capacity to administer intravenous fibrinolysis. Positive responses have been received from 13 of them so far. In case the project is accepted by the (Comité Ético de Investigación Clínica) CEIC Sant Pau, the centers that have not responded will be contacted again to obtain their participation.

Official Title
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HEROES Registry: Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke in Catalonia

Conditions
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Ischemic Stroke, Intracranial Hemorrhages, Hemorrhagic Transformation Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the criteria for being a case (remote hemorrhage) or control according to the definition of Heidelberg hemorrhagic transformations Age 18 or older Definite diagnosis of ischemic stroke (intracranial large vessel occlusion, compatible lesion on neuroimaging) Administration of a fibrinolytic drug associated or not with endovascular therapy (intravenous or local) Availability of a control brain imaging before the first 36 hours from reperfusion treatment. Exclusion Criteria: Lack of basic data (age, sex, follow-up neuroimaging, contact phone number for follow-up).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 102 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 |
| --- | --- |
| No hemorrhagic transformation<br>Patients with ischemic stroke treated with intravenous thrombolysis and no hemorrhagic transformation (IH1 or IH2 are allowed) | |
| Local hemorragic transformation<br>Patients with ischemic stroke treated with intravenous thrombolysis and hemorrhagic transformation PH1 or PH2 | |
| Remote hemorrhage<br>Patients with ischemic stroke treated with intravenous thrombolysis and remote hemorrhage in areas without evident ischemia (rPH) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the frequency and risk factors of intracranial hemorrhage during follow-up in patients with remote cerebral hemorrhage | Describe the frequency, rate and adjusted hazard ratio | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the frequency of ischemic stroke, intracerebral hemorrhage, intracranial hemorrhage, and any cerebrovascular event in patients with remote cerebral hemorrhage. | Describe the frequency, rate and adjusted hazard ratio | 24 months | 
| Investigate the net benefit of preventive treatment in patients with remote cerebral hemorrhage (composite of ischemic stroke and intracranial hemorrhage). | Evaluate the rate and adjusted hazard ratio of ischemic and hemorrhagic events | 24 months | 
| Explore the socio-functional status of patients with remote cerebral hemorrhage using the modified Rankin Scale during follow-up. | Describe the proportion of patients with favorable functional outcome measured with modified Rankin Scale (favorable is the score is 0-2) | 24 months | 
| Explore vascular mortality and overall mortality in patients with remote cerebral hemorrhage during follow-up. | Describe the frequency, rate and adjusted hazard ratio | 24 months | 
| Explore cognitive impairment follow-up | IQCODE brief test >56 points | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Thrombolysis, Hemorrhagic transformation stroke, Secondary prevention