ET-COVID-19: Endovascular Thrombectomy in COVID-19 Infected Patients

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04406090
Collaborator
(none)
50
1
3
16.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Apr 1, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Intrahospital mortality [1day]

    Intrahospital mortality after MT for COVID-19 infected patients harboring large vessel occlusion

  2. short-term morbidity [1 day]

    short-term morbidity after MT for COVID-19 infected patients harboring large vessel occlusion

Secondary Outcome Measures

  1. Angiographic success [1 day]

    Angiographic success after MT for COVID-19 infected patients harboring large vessel occlusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Principal Investigator: Federico Cagnazzo, MD PhD, UH Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04406090
Other Study ID Numbers:
  • RECHMPL20_0322
First Posted:
May 28, 2020
Last Update Posted:
Jul 29, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2020