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Ischemic StrokeNCT04895462

Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

An observational study of Ischemic Stroke and Covid19, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Covid19
Type of treatment
Injection or infusion
How many people
15,128 participants
Where
1 siteSwitzerland
Study dates
30 Apr 2021to 30 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  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)
  1. 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Lausanne University Hospital

    Lausanne

Other trials in Switzerland

About this study

Official title: 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.

Keywords
Intravenous thrombolysis, Endovascular treatment, Mechanical thrombectomy
Medical subject headings
Ischemic Stroke, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04895462
Study groupRoleWhat they receive
Ischemic Stroke and COVID-19Ischemic stroke patients with COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)
Control group: Ischemic Stroke without COVID-19Ischemic stroke patients without COVID-19 receiving acute recanalization treatment (intravenous thrombolysis and/or endovascular treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 36 hours

Secondary outcomes (10)

  1. Rate of any hemorrhagic transformation

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

    Measured: 36 hours

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

    Only in EVT patients

    Measured: End of procedure

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

    Only in EVT patients

    Measured: End of procedure

  4. Number of passes during endovascular treatment

    Only in EVT patients

    Measured: End of procedure

  5. Rate of first pass effect during endovascular treatment

    Only in EVT patients

    Measured: End of procedure

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

    Only in EVT patients

    Measured: End of procedure

  7. 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)

    Measured: 24 hours

  8. 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)

    Measured: 3 months

  9. 3-month favorable outcome

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

    Measured: 3 months

  10. 3-month mortality

    Mortality assessed at 3-month follow-up

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start30 Apr 2021
  3. Primary completion31 Aug 2021
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
15,128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895462
Sponsor's protocol ID
CHUV - Stroke&COVID
Status last verified
Mar 2023
First submitted
16 May 2021
Last updated
8 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38134260

  • 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.

    PubMed 36351814

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Covid19, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of symptomatic intracranial hemorrhage (time frame: 36 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895462, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.

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