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

• Sponsor: University of Zurich (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04573114
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 27.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Healthy	Procedure: Verticalization

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cerebral Hemodynamics During Early Verticalization After (Successful) Thrombectomy Poststroke
• Actual Study Start Date: Sep 2, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood flow velocity [within 12 hours post thrombectomy]

   Cerebral blood flow velocity measured with transcranial doppler ultrasound

Secondary Outcome Measures

1. Blood pressure [within 12 hours post thrombectomy]

   Systolic and Diastolic pressure

2. Heart rate [within 12 hours post thrombectomy]

   Number of contractions (beats) of the heart per minute

3. Oxygen saturation [within 12 hours post thrombectomy]

   Relative measure of the concentration of oxygen in the blood

4. Impairment caused by a stroke [within 12 hours post thrombectomy]

   National Institutes of Health Stroke Scale - NIHSS (Maximum score 42 - higher scores mean a worse outcome)

5. Neurological status [within 12 hours post thrombectomy]

   Glasgow Coma Scale - GCS (Maximum score 15 - higher scores mean a better outcome)

6. Adverse events [within 12 hours post thrombectomy]

   headache, focal edema, seizures, hemorrhagic transformation

Other Outcome Measures

1. Reperfusion after thrombectomy [within 12 hours post thrombectomy]

   modified Thrombolysis in Cerebral Infarction

2. Perfusion imaging [within 24 hours post thrombectomy]

   Cerebral blood flow

3. Disability [3 month post stroke]

   modified Rankin Scale - mRS (maximum score 6 - higher scores mean a worse outcome)

4. Health-related quality [3 month post stroke]

   Patient-Reported Outcomes Measurement Information System® 29

5. Independence in gait [3 month post stroke]

   Functional Ambulation Categories (Maximum score 5 - higher scores mean a better outcome)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich	Zürich	Zurich	Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04573114
• Other Study ID Numbers: 2020-01732
• First Posted: Oct 5, 2020
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 29, 2021