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Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study (PerfIRMAVC)

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: NCT02912546
Recruitment Status : Unknown
Verified June 2018 by University Hospital Center of Martinique.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:
Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in hypertensive patients and during stroke, varying degrees a various loss of cerebral autoregulation is loss are usually observed. The aim of this study is to assess cerebral perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive and stroke.

Condition or disease Intervention/treatment Phase
Brain Ischemia Procedure: MRI Not Applicable

Detailed Description:

Material and methods:

Eighteen stroke patients, eighteen hypertensive patients and eighteen healthy subjects (men and women) will be enrolled. The investigator will use a 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA).

Expected results and hypothesis:

CBF is expected to significantly vary between the supine and head down positions. It is expected to at least increase in the head down position, for stroke patients. For healthy subjects and hypertensive patients, cerebral autoregulation may limit CBF increase although an increasing trend for CBF is expected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Évaluation en IRM (séquence ASL) de la Variation de Perfusion cérébrale liée à la Position Corporelle.
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Control group
Eighteen healthy subjects and eighteen hypertensive patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA).
Procedure: MRI
A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers

Active Comparator: Stroke patients
Eighteen stroke patients (men and women) will be enrolled. A 1.5 Tesla MRI device with a large magnet bore (70 cm) will be used, allowing positions change. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS Institute, Cary North Carolina, USA).
Procedure: MRI
A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers




Primary Outcome Measures :
  1. The change in the value of the cerebral blood flow [ Time Frame: up to 1 year ]

    The endpoint is the change in the value of the cerebral blood flow ( ml / 100g / min) depending on the switching position ( 0 ° and -20 °). This development will be assessed in different brain regions . In particular, it will be searched in excess of a threshold of significance .

    This will be accomplished independently by two experienced readers (knowing that the variation between and within road has been assessed) . If a significant difference between the two players, it will be made a consensual common measure.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Group of stroke patients:

    • Patients between 40 and 70 years old, male or female
    • With supratentorial ischemia in subacute phase (> H24)
    • Patients with a recent ischemic stroke with an intracranial hemodynamic unstable and kept lying with head down of about 30
    • Patient given free and informed consent to participate in research or a family representative
    • Patient insured under the French social security system
  2. Control Group:

1- Group of patients with Hypertension.

  • Patients between 40 and 70 years old, matched for age and sex to stroke patients.
  • With a hypertension diagnosed since 10 years old.
  • Hypertension defined as three recommendations (OMS 1999, ANAES 1997 JNC VI): blood pressure 140 and / or 90 mmHg found at several consultations.

    2- Group with healthy people.

  • Healthy person between 30 and 70 years old, women and men. Healthy character will be defined on the basis of a physical examination (measurement of heart rate and blood pressure ) and an examination to determine the absence of endocrine pathology ... ) and the absence of drug outlet continuous.
  • Person insured under the French social security system.
  • Person who given free and informed his consent to participate in research or a family representative.
  • Person who are not participating in another clinical study.

Exclusion Criteria:

  • Patients aged under 40 years and 71 years and older for patients in groups of stroke patients and patients with hypertension
  • Person under 30 years and 71 years and older for healthy people
  • Person who refuses or family the participation in the study
  • Person with heart antecedent or spinal disease
  • Contraindications to the realization of a MRI (pacemaker, claustrophobia, metallic body may be mobilized).
  • Person not insured under the French social security system,
  • Pregnant women
  • Persons under guardianship or curatorship
  • Persons deprived of liberty by a judicial or administrative decision
  • Persons who are participating in another clinical study

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): NCT02912546


Contacts
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Contact: Mehdi MM MEJDOUBI, PhD +596 (0)596 55 2261 mehdi.mejdoubi@chu-fortdefrance.fr
Contact: Véronique VE ERDUAL +596 (0)596 59 26 98 veronique.erdual@chu-fortdefrance.fr

Locations
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Martinique
Centre Hospitalier Universitaire de Martinique Recruiting
Fort-de-France, Martinique, 97261
Contact: Mehdi MM MEJDOUBI, PHD    0596 55 21 81 ext +596    mehdi.mejdoubi@chu-martinique.fr   
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
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Principal Investigator: Mehdi MM MEJDOUBI, PhD CHU de Fort de France
Publications of Results:
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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT02912546    
Other Study ID Numbers: 16/B/03
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
Stroke, Acute
Additional relevant MeSH terms:
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Brain Ischemia
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases