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

Primary Purpose

Brain Ischemia

Status
Completed
Phase
Not Applicable
Locations
Martinique
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital Center of Martinique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Ischemia focused on measuring Stroke, Acute

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Martinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Stroke patients

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The change in the value of the cerebral blood flow
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.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2016
Last Updated
March 29, 2021
Sponsor
University Hospital Center of Martinique
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1. Study Identification

Unique Protocol Identification Number
NCT02912546
Brief Title
Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study
Acronym
PerfIRMAVC
Official Title
Évaluation en IRM (séquence ASL) de la Variation de Perfusion cérébrale liée à la Position Corporelle.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Ischemia
Keywords
Stroke, Acute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Stroke patients
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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 Measure Information:
Title
The change in the value of the cerebral blood flow
Description
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.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi MM MEJDOUBI, PhD
Organizational Affiliation
CHU de Fort de France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10700504
Citation
Chalela JA, Alsop DC, Gonzalez-Atavales JB, Maldjian JA, Kasner SE, Detre JA. Magnetic resonance perfusion imaging in acute ischemic stroke using continuous arterial spin labeling. Stroke. 2000 Mar;31(3):680-7. doi: 10.1161/01.str.31.3.680.
Results Reference
result
PubMed Identifier
10648324
Citation
Lovell AT, Marshall AC, Elwell CE, Smith M, Goldstone JC. Changes in cerebral blood volume with changes in position in awake and anesthetized subjects. Anesth Analg. 2000 Feb;90(2):372-6. doi: 10.1097/00000539-200002000-00025.
Results Reference
result

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Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study

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