Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke (HEROES-CAT)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Ischemic Stroke; Hemorrhagic Transformation Stroke; Intracranial Hemorrhages

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05871528

IIBSP-HER-2020-79

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 102 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who meet the criteria for being a case (remote hemorrhage) or control according to the definition of Heidelberg hemorrhagic transformations
2. Age 18 or older
3. Definite diagnosis of ischemic stroke (intracranial large vessel occlusion, compatible lesion on neuroimaging)
4. Administration of a fibrinolytic drug associated or not with endovascular therapy (intravenous or local)
5. 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).

Trial design

250 participants in 3 patient groups

No hemorrhagic transformation

Description:

Patients with ischemic stroke treated with intravenous thrombolysis and no hemorrhagic transformation (IH1 or IH2 are allowed)

Local hemorragic transformation

Description:

Patients with ischemic stroke treated with intravenous thrombolysis and hemorrhagic transformation PH1 or PH2

Remote hemorrhage

Description:

Patients with ischemic stroke treated with intravenous thrombolysis and remote hemorrhage in areas without evident ischemia (rPH)