ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02762552
Recruitment Status : Active, not recruiting
First Posted : May 5, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial-holter monitoring Not Applicable

Detailed Description:

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : September 14, 2017
Estimated Study Completion Date : May 14, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Transcranial-holter monitoring
Transcranial doppler in patient with ischemic stroke
 Device: Transcranial-holter monitoring
Transcranial holter with an 4 hour-recording


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762552


Locations
France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pauline Renou University Hospital, Bordeaux
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02762552     History of Changes
Other Study ID Numbers: CHUBX 2014/14
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Bordeaux:
Stroke
Etiology
Recurrence
Transcranial holter
Microembolic signals

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases