NCT02762552

Brief Summary

In acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. Because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 7, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 14, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

August 7, 2015

Last Update Submit

February 22, 2019

Conditions

Stroke

Keywords

StrokeEtiologyRecurrenceTranscranial holterMicroembolic signals

Outcome Measures

Primary Outcomes (2)

  • Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)

    Microembolic signals (MES) will be recorded using Transcranial-holter monitoring (index test) for 4 hours at the acute phase of ischemic stroke. The pattern will be described (frequency, laterality) by the observer interpreting recordings, blinded to stroke etiology as established by the reference standard.

    Day 0 (inclusion)

  • Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard)

    Etiologic work-up of ischemic stroke will result in ASCOD classification (reference standard) of etiology. Work-up and classification will be established blind to the pattern of microembolic signals recordede by Transcranial-holter monitoring (index test)

    Month 12

Secondary Outcomes (2)

  • Stroke recurrence

    Month 12

  • Actual duration of Transcranial-holter monitoring recording

    Day 0 (inclusion)

Study Arms (1)

Transcranial-holter monitoring

EXPERIMENTAL

Transcranial doppler in patient with ischemic stroke

Device: Transcranial-holter monitoring

Interventions

Transcranial-holter monitoringDEVICE

Transcranial holter with an 4 hour-recording

Transcranial-holter monitoring

Eligibility Criteria

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

You may qualify if:

  • Ischemic stroke in the middle cerebral artery territory
  • Acute ischemic stroke within the 7 first days from the onset of the symptoms
  • Patient hospitalized in our stroke care unit
  • Man or woman older than 18 years
  • Patient affiliated to a social security system

You may not qualify if:

  • Transient ischemic stroke
  • Ischemic stroke in the vertebro-basilar or anterior cerebral artery territory.
  • Proximal middle cerebral artery occlusion leading to the impossibility of recording
  • Patient who could not express his consent
  • Patient under guardianship or judicial protection
  • Pregnant or breastfeeding woman
  • Emergency situation
  • Life expectancy under 6 months
  • Absent of bilateral Acoustic window
  • Analyzable Recording \<30min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

StrokeRecurrence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pauline Renou

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

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

August 7, 2015

First Posted

May 5, 2016

Study Start

September 14, 2015

Primary Completion

May 11, 2017

Study Completion

August 14, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

FR(1)