NCT04573114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

September 3, 2020

Last Update Submit

November 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood flow velocity

    Cerebral blood flow velocity measured with transcranial doppler ultrasound

    within 12 hours post thrombectomy

Secondary Outcomes (6)

  • Blood pressure

    within 12 hours post thrombectomy

  • Heart rate

    within 12 hours post thrombectomy

  • Oxygen saturation

    within 12 hours post thrombectomy

  • Impairment caused by a stroke

    within 12 hours post thrombectomy

  • Neurological status

    within 12 hours post thrombectomy

  • +1 more secondary outcomes

Other Outcomes (5)

  • Reperfusion after thrombectomy

    within 12 hours post thrombectomy

  • Perfusion imaging

    within 24 hours post thrombectomy

  • Disability

    3 month post stroke

  • +2 more other outcomes

Study Arms (2)

Stroke subjects

Procedure: Verticalization

Healthy

Procedure: Verticalization

Interventions

Progressive levels of verticalization

HealthyStroke subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • First-ever ischemic stroke in the territory of the middle cerebral artery (MCA)
  • ≤12 hours after mechanical thrombectomy
  • Conscious
  • Hemodynamically stable
  • years or older
  • Informed consent of the patient and/ or legal representative

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (2)

  • 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.

  • Deseoe J, Schwarz A, Pipping T, Lehmann A, Veerbeek JM, Luft AR, Wegener S, Globas C, Held JPO. Cerebral blood flow velocity progressively decreases with increasing levels of verticalization in healthy adults. A cross-sectional study with an observational design. Front Neurol. 2023 Apr 17;14:1149673. doi: 10.3389/fneur.2023.1149673. eCollection 2023.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Luft, MD

    University of Zurich

    STUDY CHAIR

Central Study Contacts

Jeremia Held, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

October 5, 2020

Study Start

September 2, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations