Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

Completed

• Conditions: Ischemic Stroke; Covid19

• Registration Number: NCT04895462
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-16
• Study First Posted: 2021-05-20
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of first pass effect during endovascular treatment	End of procedure	Only in EVT patients
Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion)	End of procedure	Only in EVT patients
Rate of any hemorrhagic transformation	36 hours	According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition
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)
Number of passes during endovascular treatment	End of procedure	Only in EVT patients
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 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
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)

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Switzerland