Covid19, Ischemic Stroke
Conditions
Keywords
Intravenous thrombolysis, Endovascular treatment, Mechanical thrombectomy
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.
Interventions
None listed
Sponsors
Larissa University Hospital
Society of Vascular and Interventional Neurology
Hospital de Egas Moniz
Centre Hospitalier Universitaire Vaudois
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of symptomatic intracranial hemorrhage | 36 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of any hemorrhagic transformation | 36 hours | According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition |
| Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction) | End of procedure | Only in EVT patients |
| Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] ≥2b) | End of procedure | Only in EVT patients |
| Number of passes during endovascular treatment | End of procedure | Only in EVT patients |
| 3-month modified Rankin Scale (mRS) | 3 months | 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) |
| Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion) | End of procedure | Only in EVT patients |
| Delta NIHSS (National Institute of Health Stroke Scale) at 24 hours | 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) |
| 3-month favorable outcome | 3 months | Favorable outcome defined as modified Rankin Scale (mRS) ≤2 or equal to pre-stroke mRS |
| 3-month mortality | 3 months | Mortality assessed at 3-month follow-up |
| Rate of first pass effect during endovascular treatment | End of procedure | Only in EVT patients |
Countries
Switzerland
Outcome results
None listed