Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke

Healthy Clinical Trial

— CHEST  

Official title:

Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573114
• Other study ID #: 2020-01732
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: University of Zurich
• Contact: Jeremia Held, PhD
• Phone: 0442555645
• Email: jeremia.held[@]uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a proof-of-concept study with a prospective observational design, where the association between progressive levels of verticalization and cerebral blood flow velocity (Ultrasound) in subacute stroke patients and healthy subjects will be investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)

• =12 hours after mechanical thrombectomy

• Conscious

• Hemodynamically stable

• 18 years or older

• Informed consent of the patient and/ or legal representative

Exclusion Criteria:

• Verticalization not allowed according to treating physician

• Known pre-stroke disease affecting cerebral blood flow

• Temporal bone windows insufficient to enable ultrasound penetration

• Intubation anticipated or occurred

• Venous thromboembolism

• Symptomatic intracranial hemorrhage

Related Conditions & MeSH terms

• Healthy
• Stroke

Intervention

Procedure:
• Verticalization
Progressive levels of verticalization

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reperfusion after thrombectomy	modified Thrombolysis in Cerebral Infarction	within 12 hours post thrombectomy
Other	Perfusion imaging	Cerebral blood flow	within 24 hours post thrombectomy
Other	Disability	modified Rankin Scale - mRS (maximum score 6 - higher scores mean a worse outcome)	3 month post stroke
Other	Health-related quality	Patient-Reported Outcomes Measurement Information System® 29	3 month post stroke
Other	Independence in gait	Functional Ambulation Categories (Maximum score 5 - higher scores mean a better outcome)	3 month post stroke
Primary	Blood flow velocity	Cerebral blood flow velocity measured with transcranial doppler ultrasound	within 12 hours post thrombectomy
Secondary	Blood pressure	Systolic and Diastolic pressure	within 12 hours post thrombectomy
Secondary	Heart rate	Number of contractions (beats) of the heart per minute	within 12 hours post thrombectomy
Secondary	Oxygen saturation	Relative measure of the concentration of oxygen in the blood	within 12 hours post thrombectomy
Secondary	Impairment caused by a stroke	National Institutes of Health Stroke Scale - NIHSS (Maximum score 42 - higher scores mean a worse outcome)	within 12 hours post thrombectomy
Secondary	Neurological status	Glasgow Coma Scale - GCS (Maximum score 15 - higher scores mean a better outcome)	within 12 hours post thrombectomy
Secondary	Adverse events	headache, focal edema, seizures, hemorrhagic transformation	within 12 hours post thrombectomy