Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

NCT04895462 | Completed

• 1 other identifier: CHUV - Stroke&COVID
• Study Type: observational
• Target: 15,128
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Covid19

Keywords

Intravenous thrombolysis; Endovascular treatment; Mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Rate of any hemorrhagic transformation

  36 hours

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

  End of procedure

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

  End of procedure

• Number of passes during endovascular treatment

  End of procedure

• Rate of first pass effect during endovascular treatment

  End of procedure

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Larissa University Hospital: collaborator
• Society of Vascular and Interventional Neurology: collaborator
• Hospital de Egas Moniz: collaborator

Study Sites (1)

Lausanne University Hospital

Lausanne, Switzerland

Location

Related Publications (2)

• Strambo D, Marto JP, Ntaios G, Nguyen TN, Michel P; Global COVID-19 Stroke Registry. Effect of Asymptomatic and Symptomatic COVID-19 on Acute Ischemic Stroke Revascularization Outcomes. Stroke. 2024 Jan;55(1):78-88. doi: 10.1161/STROKEAHA.123.043899. Epub 2023 Dec 22.

  PMID: 38134260 DERIVED

• Marto JP, Strambo D, Ntaios G, Nguyen TN, Herzig R, Czlonkowska A, Demeestere J, Mansour OY, Salerno A, Wegener S, Baumgartner P, Cereda CW, Bianco G, Beyeler M, Arnold M, Carrera E, Machi P, Altersberger V, Bonati L, Gensicke H, Bolognese M, Peters N, Wetzel S, Magrico M, Ramos JN, Sargento-Freitas J, Machado R, Maia C, Machado E, Nunes AP, Ferreira P, Pinho E Melo T, Dias MC, Paula A, Correia MA, Castro P, Azevedo E, Albuquerque L, Alves JN, Ferreira-Pinto J, Meira T, Pereira L, Rodrigues M, Araujo AP, Rodrigues M, Rocha M, Pereira-Fonseca A, Ribeiro L, Varela R, Malheiro S, Cappellari M, Zivelonghi C, Sajeva G, Zini A, Gentile M, Forlivesi S, Migliaccio L, Sessa M, La Gioia S, Pezzini A, Sangalli D, Zedde M, Pascarella R, Ferrarese C, Beretta S, Diamanti S, Schwarz G, Frisullo G, Marcheselli S, Seners P, Sabben C, Escalard S, Piotin M, Maier B, Charbonnier G, Vuillier F, Legris L, Cuisenier P, Vodret FR, Marnat G, Liegey JS, Sibon I, Flottmann F, Broocks G, Gloyer NO, Bohmann FO, Schaefer JH, Nolte C, Audebert HJ, Siebert E, Sykora M, Lang W, Ferrari J, Mayer-Suess L, Knoflach M, Gizewski ER, Stolp J, Stolze LJ, Coutinho JM, Nederkoorn P, van den Wijngaard I, De Meris J, Lemmens R, De Raedt S, Vandervorst F, Rutgers MP, Guilmot A, Dusart A, Bellante F, Calleja-Castano P, Ostos F, Gonzalez-Ortega G, Martin-Jimenez P, Garcia-Madrona S, Cruz-Culebras A, Vera R, Matute MC, Fuentes B, Alonso-de-Lecinana M, Rigual R, Diez-Tejedor E, Perez-Sanchez S, Montaner J, Diaz-Otero F, Perez-de-la-Ossa N, Flores-Pina B, Munoz-Narbona L, Chamorro A, Rodriguez-Vazquez A, Renu A, Ayo-Martin O, Hernandez-Fernandez F, Segura T, Tejada-Meza H, Sagarra-Mur D, Serrano-Ponz M, Hlaing T, See I, Simister R, Werring D, Kristoffersen ES, Nordanstig A, Jood K, Rentzos A, Simunek L, Krajickova D, Krajina A, Mikulik R, Cvikova M, Vinklarek J, Skoloudik D, Roubec M, Hurtikova E, Hruby R, Ostry S, Skoda O, Pernicka M, Jurak L, Eichlova Z, Jira M, Kovar M, Pansky M, Mencl P, Palouskova H, Tomek A, Jansky P, Olserova A, Sramek M, Havlicek R, Maly P, Trakal L, Fiksa J, Slovak M, Karlinski MA, Nowak M, Sienkiewicz-Jarosz H, Bochynska A, Wrona P, Homa T, Sawczynska K, Slowik A, Wlodarczyk E, Wiacek M, Tomaszewska-Lampart I, Sieczkowski B, Bartosik-Psujek H, Bilik M, Bandzarewicz A, Dorobek M, Zielinska-Turek J, Nowakowska-Kotas M, Obara K, Urbanowski P, Budrewicz S, Guzinski M, Switonska M, Rutkowska I, Sobieszak-Skura P, Labuz-Roszak BM, Debiec A, Staszewski J, Stepien A, Zwiernik J, Wasilewski G, Tiu C, Terecoasa EO, Radu RA, Negrila A, Dorobat B, Panea C, Tiu V, Petrescu S, Ozdemir A, Mahmoud M, El-Samahy H, Abdelkhalek H, Al-Hashel J, Ismail II, Salmeen A, Ghoreishi A, Sabetay SI, Gross H, Klein P, Abdalkader M, Jabbour P, El Naamani K, Tjoumakaris S, Abbas R, Mohamed GA, Chebl A, Min J, Hovingh M, Tsai JP, Khan M, Nalleballe K, Onteddu S, Masoud H, Michael M, Kaur N, Maali L, Abraham MG, Khandelwal P, Bach I, Ong M, Babici D, Khawaja AM, Hakemi M, Rajamani K, Cano-Nigenda V, Arauz A, Amaya P, Llanos N, Arango A, Vences MA, Barrientos Guerra JD, Caetano R, Martins RT, Scollo SD, Yalung PM, Nagendra S, Gaikwad A, Seo KD, Georgiopoulos G, Nogueira RG, Michel P; Global COVID-19 Stroke Registry. Safety and Outcome of Revascularization Treatment in Patients With Acute Ischemic Stroke and COVID-19: The Global COVID-19 Stroke Registry. Neurology. 2023 Feb 14;100(7):e739-e750. doi: 10.1212/WNL.0000000000201537. Epub 2022 Nov 9.

  PMID: 36351814 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; COVID-19

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: João Pedro Marto

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: April 30, 2021
• Primary Completion: August 31, 2021
• Study Completion: October 30, 2021
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

CH (1)