NCT05871528

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

May 4, 2023

Last Update Submit

May 12, 2023

Conditions

Ischemic StrokeIntracranial HemorrhagesHemorrhagic Transformation Stroke

Keywords

Ischemic strokeThrombolysisHemorrhagic transformation strokeSecondary prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Explore the frequency of ischemic stroke, intracerebral hemorrhage, intracranial hemorrhage, and any cerebrovascular event in patients with remote cerebral hemorrhage.

    24 months

  • Investigate the net benefit of preventive treatment in patients with remote cerebral hemorrhage (composite of ischemic stroke and intracranial hemorrhage).

    24 months

  • Explore the socio-functional status of patients with remote cerebral hemorrhage using the modified Rankin Scale during follow-up.

    24 months

  • Explore vascular mortality and overall mortality in patients with remote cerebral hemorrhage during follow-up.

    24 months

  • Explore cognitive impairment follow-up

    24 months

Study Arms (3)

No hemorrhagic transformation

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

Local hemorragic transformation

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

Remote hemorrhage

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

Eligibility Criteria

Age18 Years - 102 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study outlines a four-step process to identify and select cases for a study on remote hemorrhages with or without local hemorrhagic transformation. The first step is to identify cases by evaluating control neuroimaging, and if there are doubts, investigators can seek consensus decision-making. The second step is to select four controls for each case, two without hemorrhagic transformation and two with type 2 hemorrhagic transformation. The third step involves completing the CICAT registry form and additional variables, some of which are optional. The fourth and final step is to conduct telephone follow-up at 3, 12, and 24 months to collect variables of interest in relation to the study's objectives.

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of basic data (age, sex, follow-up neuroimaging, contact phone number for follow-up).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luis Prats Sanchez, MD PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Prats Sanchez, MD PhD

CONTACT

+34935565986lpratss@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 23, 2023

Study Start

May 1, 2021

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

ES(1)