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

Summary

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.

Conditions

• Ischemic Stroke
• Intracranial Hemorrhages
• Hemorrhagic Transformation Stroke

Sponsors & Collaborators

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital de Granollers

  collaborator OTHER

• Hospital Arnau de Vilanova

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Consorci Sanitari del Garraf

  collaborator OTHER

• Hospital de Sant Joan Despí Moisès Broggi

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Agència de Qualitat i Avaluació Sanitàries

  collaborator OTHER_GOV

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

  lead OTHER

Principal Investigators

• Luis Prats Sanchez, MD PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eligibility

Min Age

18 Years

Max Age

102 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2025-05-01

Completion

2025-05-01

Countries

• Spain

Study Locations