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NCT Number: NCT04895462

Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases COVID-19 Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital

Lausanne, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Rate of symptomatic intracranial hemorrhage

    Time frame: 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 outcomes

  1. Rate of any hemorrhagic transformation

    Time frame: 36 hours

    According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition

  2. Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction)

    Time frame: End of procedure

    Only in EVT patients

  3. Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] ≥2b)

    Time frame: End of procedure

    Only in EVT patients

  4. Number of passes during endovascular treatment

    Time frame: End of procedure

    Only in EVT patients

  5. Rate of first pass effect during endovascular treatment

    Time frame: End of procedure

    Only in EVT patients

  6. Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion)

    Time frame: End of procedure

    Only in EVT patients

  7. Delta NIHSS (National Institute of Health Stroke Scale) at 24 hours

    Time frame: 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)

  8. 3-month modified Rankin Scale (mRS)

    Time frame: 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)

  9. 3-month favorable outcome

    Time frame: 3 months

    Favorable outcome defined as modified Rankin Scale (mRS) ≤2 or equal to pre-stroke mRS

  10. 3-month mortality

    Time frame: 3 months

    Mortality assessed at 3-month follow-up

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • Hospital de Egas Moniz
  • Larissa University Hospital
  • Society of Vascular and Interventional Neurology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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