Clinical trial NCT04895462: Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19
Official title: Safety and Outcomes of Acute Revascularization Treatment in COVID Patients: an International Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Covid19
Keywords: Intravenous thrombolysis
Endovascular treatment
Mechanical thrombectomy
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Larissa University Hospital
name: Society of Vascular and Interventional Neurology
name: Hospital de Egas Moniz
First posted: 2021-05-20
Enrollment: 15128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Exposed group - Patients with COVID-19

   * Community-acquired confirmed case of SARS-CoV-2 infection either by a positive PCR- or antigen test, and independently of the presence of identifiable COVID-19 compatible symptoms
   * Patient hospitalized due to COVID-19 and with in-hospital stroke
   * Patients with COVID-19 compatible symptoms before reperfusion treatment and with PCR- or antigen test becoming positive within the first 7 days after treatment
2. Non-exposed group - Patients without COVID-19 ("controls")

   * Patients without COVID-19 compatible symptoms and with negative PCR- or antigen test within the first 7 days after treatment

Brief summary: Case-series and cohort studies have shown the feasibility of reperfusion therapies in patients with ischemic stroke and COVID-19, but due to the absence of a contemporary control group of non-COVID-19 patients, small sample size or lack of long-term outcome assessment, concerns regarding safety and efficacy of these treatments remain to be clarified. Taking into account its limitations, some studies documented higher rates of endovascular treatment complications such as clot fragmentation with distal embolization and vessel re-oclusion, to be more difficult to achieve recanalization after endovascular treatment, and higher rates of any intracerebral hemmorhage.

The investigators aim is to assess in a large, multicenter and international cohort, the safety and outcomes of acute reperfusion therapies in patients with ischemic stroke and COVID-19, by comparison with a contemporary control group of patients with ischemic stroke and without COVID-19 from the same centers.


Eligibility criteria: 1. Inclusion Criteria:

   * Consecutive ischemic stroke patients receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment) up to 24 hours since last time since well, and according to local treatment criteria
   * From 1st of March 2020 (for Chinese Centers from 1st January 2020)
2. Exclusion Criteria:

   * Patients without a PCR- or antigen test within the first 7 days after treatment
   * Patients with nosocomial SARS-CoV-2 infection after receiving acute recanalization treatment - PCR- or antigen test becoming positive more than 7 days after treatment
   * Patients with "Suspect/ probable case of SARS-CoV-2 infection" according to the World Health Organization definition
   * Symptomatic cases of SARS-CoV-2 infection with symptoms resolution more than 7 days before treatment
   * Asymptomatic cases of SARS-CoV-2 infection with treatment performed more than 10 days after first positive test for SARS-CoV-2

Primary outcomes:
measure: Rate of symptomatic intracranial hemorrhage
timeFrame: 36 hours
Secondary outcomes:
measure: Rate of any hemorrhagic transformation
timeFrame: 36 hours
measure: Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction)
timeFrame: End of procedure
measure: Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] ≥2b)
timeFrame: End of procedure
measure: Number of passes during endovascular treatment
timeFrame: End of procedure
measure: Rate of first pass effect during endovascular treatment
timeFrame: End of procedure
measure: Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion)
timeFrame: End of procedure
measure: Delta NIHSS (National Institute of Health Stroke Scale) at 24 hours
timeFrame: 24 hours
measure: 3-month modified Rankin Scale (mRS)
timeFrame: 3 months
measure: 3-month favorable outcome
timeFrame: 3 months
measure: 3-month mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
Study officials:
affiliation: Stroke Center, Department of Neurology, Lausanne University Hospital, Lausanne, Switzerland and Deparment of Neurology, Hospital de Egas Moniz, Lisbon, Portugal
name: João Pedro Marto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
name: George Ntaios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland
name: Davide Strambo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland
name: Patrik Michel, MD
role: PRINCIPAL_INVESTIGATOR
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