Acute Revascularization Treatment in Ischemic Stroke Patients With COVID-19

Covid19 Clinical Trial

Official title:

Safety and Outcomes of Acute Revascularization Treatment in COVID Patients: an International Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895462
• Other study ID #: CHUV - Stroke&COVID
• Status: Completed
• Start date: April 30, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15128
• Est. completion date: October 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

2. 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Ischemia
• Ischemic Stroke

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	Hospital de Egas Moniz, Larissa University Hospital, Society of Vascular and Interventional Neurology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	36 hours
Secondary	Rate of any hemorrhagic transformation	According to the ECASS-2 (European-Australasian Acute Stroke Study - II) definition	36 hours
Secondary	Rate of recanalization after endovascular treatment measured by mTICI (modified treatment in cerebral infarction)	Only in EVT patients	End of procedure
Secondary	Rate of successful recanalization after endovascular treatment (defined as final mTICI [modified treatment in cerebral infarction] =2b)	Only in EVT patients	End of procedure
Secondary	Number of passes during endovascular treatment	Only in EVT patients	End of procedure
Secondary	Rate of first pass effect during endovascular treatment	Only in EVT patients	End of procedure
Secondary	Rate of procedural complication (Arterial perforation, embolization into a previously non-ischemic territory, and re-occlusion)	Only in EVT patients	End of procedure
Secondary	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)	24 hours
Secondary	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)	3 months
Secondary	3-month favorable outcome	Favorable outcome defined as modified Rankin Scale (mRS) =2 or equal to pre-stroke mRS	3 months
Secondary	3-month mortality	Mortality assessed at 3-month follow-up	3 months