Skip to main content
OpenTrials
Completed

NCT Number: NCT02762552

Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

About this study

Asymptomatic MES detected by transcranial doppler have been reported in patient with ischemic stroke. It has been previously demonstrated that MES predict stroke recurrence and that the frequency of MES depends on stroke etiology. However, the pattern of MES has never been correlated to stroke etiology. Transcranial-holter is a novel ambulatory system which allows prolonged recording (up to 4 hours) leading to an increased detection of MES.

Therefore, transcranial holter with an 4 hour-recording will be performed for consecutive eligible patients hospitalized in our stroke care unit. During the recording, the patient will be able to continue their usual activities (eating, walking, speaking and sleeping).

All the included patients will have a classical follow-up at 3, 6 months and 12 months. The neurologist, blinded to the results of transcranial-holter, will have to prescribe and analyze the results of diagnostic tests to identify stroke etiology. Stroke etiology will be established according to the ASCOD classification. Questioning and neurological exam (NIHSS score) will be performed looking for potential recurrent stroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion criteria

  • 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

Exclusion criteria

(after inclusion) :

  • Absent of bilateral Acoustic window
  • Analyzable Recording <30min

Treatment and study plan

Transcranial-holter monitoring

Device

Transcranial holter with an 4 hour-recording

Primary outcomes

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

    Time frame: Day 0 (inclusion)

    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.

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

    Time frame: Month 12

    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)

Secondary outcomes

  1. Stroke recurrence

    Time frame: Month 12

    Existence of a stroke recurrence will be assessed by clinical examination and possibly additional tests (imaging,..)

  2. Actual duration of Transcranial-holter monitoring recording

    Time frame: Day 0 (inclusion)

    Actual duration of Transcranial-holter monitoring recording (minutes) will be measured (expected duration 4 hours) as a feasibility criterion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup

Acronym: HOLISTER

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 5, 2016
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.