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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04895462
Other study ID # CHUV - Stroke&COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date October 30, 2021

Study information

Verified date March 2023
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15128
Est. completion date October 30, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Lausanne University Hospital Lausanne

Sponsors (4)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois Hospital de Egas Moniz, Larissa University Hospital, Society of Vascular and Interventional Neurology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of any hemorrhagic transformation According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition 36 hours
Secondary Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction) Only in EVT patients End of procedure
Secondary Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] =2b) Only in EVT patients End of procedure
Secondary Number of passes during endovascular treatment Only in EVT patients End of procedure
Secondary Rate of first pass effect during endovascular treatment Only in EVT patients End of procedure
Secondary Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion) Only in EVT patients End of procedure
Secondary 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
Secondary 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
Secondary 3-month favorable outcome Favorable outcome defined as modified Rankin Scale (mRS) =2 or equal to pre-stroke mRS 3 months
Secondary 3-month mortality Mortality assessed at 3-month follow-up 3 months
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