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Endovascular Thrombectomy in COVID-19 Infected Patients (ET-COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406090
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.


Condition or disease Intervention/treatment
Ischemic Stroke Covid 19 Other: Mechanical Trombectomy

Detailed Description:

Since the identification of the first case of Severe Acute Respiratory Syndrome (SARS) CoV-2 infection in December 2019 in Wuhan, China, the global number of confirmed COVID-19 cases is roughly 5 000 000, with 216 involved countries. Increasing evidence shows that SARS-CoV-2 may be associated with neurological manifestations, with up to 36% of patients showing neurological symptoms related to the neurovirulence of the SARS-CoV-2.

It has been reported that roughly 5% of COVID-19 infected patients may present acute ischemic stroke (AIS), and these patients may have an unfavorable clinical evolution due to the systemic involvement of the infective disease. In addition, these patients are quite young: the mean age of COVID-19 patients having AIS is lower (56 years), compared to general population of AIS patients (mean age=73 years). Moreover, most of these patients require an intensive care units (ICU) management. Stroke mechanisms may be multiple and can include hypercoagulability from critical illness, cardioembolism from virus-related cardiac injury, and severe inflammation. Indeed, the dysfunction of endothelial cells induced by infection may promote an increased thrombin generation and fibrinolysis; moreover, the hypoxia found in severe COVID-19 patients can be a trigger for thrombosis, increasing blood viscosity, and inducing hypoxia-inducible transcription factors.

Outcomes related to the treatment of COVID-19 patients harboring large vessel occlusion and requiring MT is substantially unknown, but it is likely that the combined morbidity and mortality rate of the two pathologies is high. Accordingly, patient's selection, treatment-management, and results should be urgently elucidated.

Involving 4 different countries (France, Italy, Spain, and US), this multicentric cohort study aims to analyze the largest possible number of COVID-19 infected patients treated with MT for AIS, with the intention to provide treatment-results and neurological outcomes, elucidating the best patient-selection and treatment-management.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Intervention Details:
  • Other: Mechanical Trombectomy
    Stent retriever for treatment of cerebral arterial occlusions


Primary Outcome Measures :
  1. Intrahospital mortality [ Time Frame: 1day ]
    Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion

  2. short-term morbidity [ Time Frame: 1 day ]
    short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion


Secondary Outcome Measures :
  1. Angiographic success [ Time Frame: 1 day ]
    Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion


Biospecimen Retention:   None Retained
NC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients >18 years infected with the SARR-CoV-2, presenting an acute ischemic stroke, and eligible to be treated with mechanical thrombectomy (based on the current guide-lines)
Criteria

Inclusion criteria:

- Patients >18 years infected with the SARR-CoV-2 with acute ischemic stroke, and eligible for mechanical thrombectomy (based on the current guide-lines)

Exclusion criteria:

- Patients <18 years ; no eligibility to mechanical thrombectomy ; absence of diagnosis of COVID-19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406090


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Federico Cagnazzo, MD PhD UH Montpellier
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04406090    
Other Study ID Numbers: RECHMPL20_0322
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Acute ischemic stroke related to large vessel occlusion
Mechanical Trombectomy
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes