NCT05878002

Brief Summary

The goal of this interventional study is to learn about the clinical outcomes of acute ischemic stroke treated with mechanical thrombectomy resulting in a selective ischemia of the basal ganglia. The main question it aims to answer is: • defining the prevalence and clinical features of possible cognitive, motor and sleep disfuncions occuring after acute ischemic stroke treated with thrombectomy Participants will be tested for cognitive, movement and sleep disorders in the acute phase and successively in the long term follow-up.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
95mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Apr 2023Apr 2034

Study Start

First participant enrolled

April 12, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2033

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

May 26, 2023

Status Verified

April 1, 2023

Enrollment Period

10 years

First QC Date

April 26, 2023

Last Update Submit

May 17, 2023

Conditions

Post-stroke Disorders

Outcome Measures

Primary Outcomes (1)

  • Post-stroke cognitive dysfunction

    Assessment through the MoCA (Montreal Cognitive Assessment) score of cognitive dysfunction in patients with acute ischemic stroke treated with mechanical thrombectomy

    Within 72 hours

Study Arms (1)

Patients affected by acute ischemic stroke treated with mechanical thrombectomy

OTHER
Device: polysomnography

Interventions

polysomnographyDEVICE

Sleep study through polysomnographic examination

Patients affected by acute ischemic stroke treated with mechanical thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participant's age ≥ 18 years
  • acute ischemic stroke due to occlusion of proximal middle cerebral artery successfully treated with mechanical thrombectomy (mTICI ≥ 2B)
  • signature of specific written informed consent

You may not qualify if:

  • unstable clinical conditions
  • personal history of cognitive decline before the acute ischemic stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flavia Torlizzi

Rome, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Carla Piano

CONTACT

0630156433carla.piano@policlinicogemelli.it

Flavia Torlizzi

CONTACT

0630156433flavia.torlizzi@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 26, 2023

Study Start

April 12, 2023

Primary Completion (Estimated)

April 12, 2033

Study Completion (Estimated)

April 1, 2034

Last Updated

May 26, 2023

Record last verified: 2023-04

Locations

IT(1)