Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Ischemic Stroke

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: João Pedro Marto, MD; Phone Number: +351210432179; Email: joao.pedro.seabra.marto@gmail.com

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Recruiting
    • Lausanne University Hospital
    • Contact: Patrik Michel, MD; Email: Patrik.Michel@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Exposed group - Patients with COVID-19

   • Community-acquired confirmed case of SARS-CoV-2 infection either by a positive PCR- or antigen test, and independently of the presence of identifiable COVID-19 compatible symptoms
   • Patient hospitalized due to COVID-19 and with in-hospital stroke
   • Patients with COVID-19 compatible symptoms before reperfusion treatment and with PCR- or antigen test becoming positive within the first 7 days after treatment

2. Non-exposed group - Patients without COVID-19 ("controls")

   • Patients without COVID-19 compatible symptoms and with negative PCR- or antigen test within the first 7 days after treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ischemic Stroke and COVID-19; Ischemic stroke patients with COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)
Control group: Ischemic Stroke without COVID-19; Ischemic stroke patients without COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Larissa University Hospital; Hospital de Egas Moniz; Society of Vascular and Interventional Neurology
• Investigators: Principal Investigator: João Pedro Marto, MD, Stroke Center, Department of Neurology, Lausanne University Hospital, Lausanne, Switzerland and Deparment of Neurology, Hospital de Egas Moniz, Lisbon, Portugal; Principal Investigator: George Ntaios, MD, PhD, Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece; Principal Investigator: Davide Strambo, MD, Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland; Principal Investigator: Patrik Michel, MD, Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2021
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): October 30, 2021

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (ACTUAL): May 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Endovascular treatment; Mechanical thrombectomy; Intravenous thrombolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stroke; COVID-19; Ischemic Stroke; Ischemia
• Other Study ID Numbers: CHUV - Stroke&COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No