Endovascular Thrombectomy in COVID-19 Infected Patients (ET-COVID-19)
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|ClinicalTrials.gov Identifier: NCT04406090|
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : July 29, 2020
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|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|
- Other: Mechanical Trombectomy
Stent retriever for treatment of cerebral arterial occlusions
- Intrahospital mortality [ Time Frame: 1day ]Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion
- short-term morbidity [ Time Frame: 1 day ]short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion
- Angiographic success [ Time Frame: 1 day ]Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion
Biospecimen Retention: None Retained
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
|Montpellier, France, 34295|
|Principal Investigator:||Federico Cagnazzo, MD PhD||UH Montpellier|