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出境医 / 临床实验 / Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND)

Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND)

Study Description
Brief Summary:

The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.

The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.


Condition or disease Intervention/treatment
Stroke Other: Transcranial Doppler

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : February 15, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Cases
Patients with ischemic stroke or transient ischemic attack who have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.
 Other: Transcranial Doppler

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the helmet.
Controls
Patients with ischemic stroke or transient ischemic attack who do not have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.
 Other: Transcranial Doppler

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the helmet.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler [ Time Frame: 2 minutes ]
    Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler (defined by a variation of more than 10%) on the symptomatic side evaluated in transcranial Doppler when changing from the lying position (0°) to the 90° position (measured 2 minutes after verticalization).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited during their hospitalization in the USINV for the management of ischemic stroke.
Criteria

Inclusion Criteria:

  • Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery
  • Duration of symptoms less than 48 hours
  • Absence of homolateral or downstream intracranial stenosis or occlusion M1
  • Lifting authorized by the referent clinician.

  • Rankin's score before AIC/AIT ≤ 2

    • For cases:

  • Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion

    • For controls:

  • Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion

Exclusion Criteria:

- Disrupted vigilance

Secondary exclusion criteria:

  • Absence of a homolateral temporal acoustic window at the lesion
  • Impossibility to verticalize the patient
Contacts and Locations

Locations
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France
Fondation Ophtalmique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Tracking Information
First Submitted Date June 11, 2019
First Posted Date June 13, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date November 15, 2019
Actual Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2019) 		Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler [ Time Frame: 2 minutes ]
Percentage of patients with a change in mean cerebral artery velocity (MCAVM) in transcranial Doppler (defined by a variation of more than 10%) on the symptomatic side evaluated in transcranial Doppler when changing from the lying position (0°) to the 90° position (measured 2 minutes after verticalization).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction
Official Title Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)
Brief Summary

The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.

The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited during their hospitalization in the USINV for the management of ischemic stroke.
Condition Stroke
Intervention Other: Transcranial Doppler

Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet.

After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the helmet.
Study Groups/Cohorts
  • Cases
    Patients with ischemic stroke or transient ischemic attack who have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.
    Intervention: Other: Transcranial Doppler
  • Controls
    Patients with ischemic stroke or transient ischemic attack who do not have carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion.
    Intervention: Other: Transcranial Doppler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 26, 2021) 		36
Original Estimated Enrollment
 (submitted: June 11, 2019) 		40
Actual Study Completion Date February 15, 2021
Actual Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery
  • Duration of symptoms less than 48 hours
  • Absence of homolateral or downstream intracranial stenosis or occlusion M1
  • Lifting authorized by the referent clinician.

  • Rankin's score before AIC/AIT ≤ 2

    • For cases:

  • Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion

    • For controls:

  • Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion

Exclusion Criteria:

- Disrupted vigilance

Secondary exclusion criteria:

  • Absence of a homolateral temporal acoustic window at the lesion
  • Impossibility to verticalize the patient
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03985059
Other Study ID Numbers MMI_2018_12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date March 2021

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