Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke (CHEST)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Healthy
• Intervention / Treatment: Procedure: Verticalization

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Jeremia Held, PhD; Phone Number: 41 0442555645; Email: jeremia.held@uzh.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Jeremia Held, PhD; Phone Number: 41 0442555645; Email: jeremia.held@uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke subjects	Procedure: Verticalization; Progressive levels of verticalization
Healthy	Procedure: Verticalization; Progressive levels of verticalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow velocity	Cerebral blood flow velocity measured with transcranial doppler ultrasound	within 12 hours post thrombectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and Diastolic pressure	within 12 hours post thrombectomy
Heart rate	Number of contractions (beats) of the heart per minute	within 12 hours post thrombectomy
Oxygen saturation	Relative measure of the concentration of oxygen in the blood	within 12 hours post thrombectomy
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
Neurological status	Glasgow Coma Scale - GCS (Maximum score 15 - higher scores mean a better outcome)	within 12 hours post thrombectomy
Adverse events	headache, focal edema, seizures, hemorrhagic transformation	within 12 hours post thrombectomy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reperfusion after thrombectomy	modified Thrombolysis in Cerebral Infarction	within 12 hours post thrombectomy
Perfusion imaging	Cerebral blood flow	within 24 hours post thrombectomy
Disability	modified Rankin Scale - mRS (maximum score 6 - higher scores mean a worse outcome)	3 month post stroke
Health-related quality	Patient-Reported Outcomes Measurement Information System® 29	3 month post stroke
Independence in gait	Functional Ambulation Categories (Maximum score 5 - higher scores mean a better outcome)	3 month post stroke

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Chair: Andreas Luft, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-01732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No