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Assessment of Venous Drainage in Idiopathic Intracranial Hypertension (HYPERPIC)

Primary Purpose

Intracranial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI examination
ECG
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Hypertension focused on measuring Intracranial Hypertension, venous drainage, MRI, blood flow, cerebrospinal fluid flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age : >18 years old
  • adult patients referred to the imaging department for intracranial hypertension assessment
  • adult control subjects without history of cerebral or vascular pathology

Exclusion Criteria:

  • history of cerebral or vascular pathology for the control subjects
  • pregnant woman
  • claustrophobia
  • major obesity
  • any contraindication to MRI exam

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

idiopathic intracranial hypertension

healthy subjects

Arm Description

patients with idiopathic intracranial hypertension

Healthy subjects

Outcomes

Primary Outcome Measures

Ratio between jugular vein flow and total arterial brain flow.
Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.

Secondary Outcome Measures

CSF (cerebrospinal fluid) Stroke volumes
CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels

Full Information

First Posted
October 3, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04115553
Brief Title
Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
Acronym
HYPERPIC
Official Title
Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

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
Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.
Detailed Description
The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
Intracranial Hypertension, venous drainage, MRI, blood flow, cerebrospinal fluid flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
idiopathic intracranial hypertension
Arm Type
Experimental
Arm Description
patients with idiopathic intracranial hypertension
Arm Title
healthy subjects
Arm Type
Sham Comparator
Arm Description
Healthy subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI examination
Other Intervention Name(s)
Magnetic resonance imaging (MRI)
Intervention Description
Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. Standard MRI examination using a 32-channel head coil consists of angiographic, morphological and phase-contrast 2D flow sequences. The flow planes are set perpendicularly to the structure axis (blood or CSF regions). The velocity measured in the pixels inside the region of interest allow the calculation of a mean flow rate as well as the volume displaced during a cardiac cycle.
Intervention Type
Diagnostic Test
Intervention Name(s)
ECG
Other Intervention Name(s)
Electrocardiogram
Intervention Description
A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
Primary Outcome Measure Information:
Title
Ratio between jugular vein flow and total arterial brain flow.
Description
Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.
Time Frame
day 0 = day of inclusion
Secondary Outcome Measure Information:
Title
CSF (cerebrospinal fluid) Stroke volumes
Description
CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels
Time Frame
day 0 = day of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age : >18 years old adult patients referred to the imaging department for intracranial hypertension assessment adult control subjects without history of cerebral or vascular pathology Exclusion Criteria: history of cerebral or vascular pathology for the control subjects pregnant woman claustrophobia major obesity any contraindication to MRI exam
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Baledent, Dr
Phone
(33)322089520
Email
baledent.olivier@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc Constans, Pr
Phone
(33)322087511
Email
constans.jean-marc@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Salouël
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Baledent, DR
Phone
(33)322089520
Email
baledent.olivier@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
jean-marc constans, PR
Phone
(33)322087511
Email
constans.jean-marc@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Cyrille Capel, DR

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

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