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

Ischemic Stroke Clinical Trial

— HEROES-CAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871528
• Other study ID #: IIBSP-HER-2020-79
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Luis Prats Sanchez, MD PhD
• Phone: +34935565986
• Email: lpratss[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 102 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Hemorrhage
• Hemorrhagic Transformation Stroke
• Intracranial Hemorrhages
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña

Sponsors (13)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Agència de Qualitat i Avaluació Sanitàries, Consorci Sanitari del Garraf, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova, Hospital Clinic of Barcelona, Hospital de Granollers, Hospital de Sant Joan Despí Moisès Broggi, Hospital del Mar, Hospital Parc Taulí, Sabadell, Hospital Universitari de Bellvitge, Hospital Vall d'Hebron, University Hospital of Girona Dr.Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Explore cognitive impairment follow-up	IQCODE brief test >56 points	24 months