Cerebral Hemodynamics During Early Verticalization After... | NCT04573114

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

NCT04573114

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Nov 29, 2021Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Stroke
Healthy

Interventions

Verticalization

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2021

Last Update Posted Date

Nov 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke subjects			Procedure: Verticalization
Healthy			Procedure: Verticalization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verticalization	Procedure	Progressive levels of verticalization	Healthy Stroke subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Reperfusion after thrombectomy	modified Thrombolysis in Cerebral Infarction	within 12 hours post thrombectomy
Perfusion imaging	Cerebral blood flow

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeremia Held, PhD	Contact	0442555645	41	jeremia.held@uzh.ch

Overall Officials

Name	Affiliation	Role
Andreas Luft, MD	University of Zurich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich	Recruiting	Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41567543	Derived	Deseoe J, Rottenberger Y, Pipping T, Schwarz A, Lehmann A, Veerbeek JM, Wegener S, Luft AR, Held JPO, Globas C. Very early tilt-table verticalization unmasks impaired cerebral autoregulation within 24 h after endovascular thrombectomy: a transcranial Doppler study. Front Neurol. 2026 Jan 6;16:1709991. doi: 10.3389/fneur.2025.1709991. eCollection 2025.
37139076

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases