Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Outcomes of Acute Revascularization Treatment in COVID Patients: an International Comparative Study

Conditions
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Ischemic Stroke, Covid19

Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ischemic Stroke and COVID-19<br>Ischemic stroke patients with COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment) | |
| Control group: Ischemic Stroke without COVID-19<br>Ischemic stroke patients without COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of symptomatic intracranial hemorrhage | Symptomatic parenchymal hemorrhagic transformation according to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition, and/or subarachnoid hemorrhage with ≥4-point worsening in NIHSS (National Institute of Health Stroke Scale) | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of any hemorrhagic transformation | According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition | 36 hours | 
| Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction) | Only in EVT patients | End of procedure | 
| Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] ≥2b) | Only in EVT patients | End of procedure | 
| Number of passes during endovascular treatment | Only in EVT patients | End of procedure | 
| Rate of first pass effect during endovascular treatment | Only in EVT patients | End of procedure | 
| Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion) | Only in EVT patients | End of procedure | 
| Delta NIHSS (National Institute of Health Stroke Scale) at 24 hours | Difference between admission NIHSS and NIHSS at 24 hours. NIHSS is a scale used to quantify the severity of neurological deficits after stroke: 0 (no signs) to 42 (very severe stroke) | 24 hours | 
| 3-month modified Rankin Scale (mRS) | Functional outcome assessed with mRS at 3-month follow-up. The mRS is an ordinal scale that assigns patients among 7 levels of disability: 0 (no symptom) to 5 (severe disability) and 6 (death) | 3 months | 
| 3-month favorable outcome | Favorable outcome defined as modified Rankin Scale (mRS) ≤2 or equal to pre-stroke mRS | 3 months | 
| 3-month mortality | Mortality assessed at 3-month follow-up | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous thrombolysis, Endovascular treatment, Mechanical thrombectomy