Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

NCT ID: NCT04895462

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-10-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ischemic Stroke and COVID-19

Ischemic stroke patients with COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)

No interventions assigned to this group

Control group: Ischemic Stroke without COVID-19

Ischemic stroke patients without COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Larissa University Hospital

OTHER

Sponsor Role: collaborator

Society of Vascular and Interventional Neurology

UNKNOWN

Sponsor Role: collaborator

Hospital de Egas Moniz

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Joao Pedro Marto

João Pedro Marto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Pedro Marto, MD

Role: PRINCIPAL_INVESTIGATOR

Stroke Center, Department of Neurology, Lausanne University Hospital, Lausanne, Switzerland and Deparment of Neurology, Hospital de Egas Moniz, Lisbon, Portugal

George Ntaios, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece

Davide Strambo, MD

Role: PRINCIPAL_INVESTIGATOR

Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland

Patrik Michel, MD

Role: PRINCIPAL_INVESTIGATOR

Stroke Centre, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland

Locations

Lausanne University Hospital

Lausanne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 38134260 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36351814 (View on PubMed)

Other Identifiers

CHUV - Stroke&COVID

Identifier Type: -

Identifier Source: org_study_id