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Trial record 4 of 39 for:    idiopathic intracranial hypertension

Assessment of Venous Drainage in Idiopathic Intracranial Hypertension (HYPERPIC)

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ClinicalTrials.gov Identifier: NCT04115553
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Intracranial Hypertension Diagnostic Test: MRI examination Diagnostic Test: ECG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: idiopathic intracranial hypertension
patients with idiopathic intracranial hypertension
Diagnostic Test: MRI examination
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.
Other Name: Magnetic resonance imaging (MRI)

Diagnostic Test: ECG
A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
Other Name: Electrocardiogram

Sham Comparator: healthy subjects
Healthy subjects
Diagnostic Test: MRI examination
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.
Other Name: Magnetic resonance imaging (MRI)

Diagnostic Test: ECG
A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
Other Name: Electrocardiogram




Primary Outcome Measures :
  1. Ratio between jugular vein flow and total arterial brain flow. [ Time Frame: day 0 = day of inclusion ]
    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 :
  1. CSF (cerebrospinal fluid) Stroke volumes [ Time Frame: day 0 = day of inclusion ]
    CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04115553


Contacts
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Contact: Olivier Baledent, Dr (33)322089520 baledent.olivier@chu-amiens.fr
Contact: Jean-Marc Constans, Pr (33)322087511 constans.jean-marc@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Salouël, France, 80480
Contact: Olivier Baledent, DR    (33)322089520    baledent.olivier@chu-amiens.fr   
Contact: jean-marc constans, PR    (33)322087511    constans.jean-marc@chu-amiens.fr   
Principal Investigator: Cyrille Capel, DR         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04115553    
Other Study ID Numbers: PI2019_843_0056
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
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 Centre Hospitalier Universitaire, Amiens:
Intracranial Hypertension
venous drainage
MRI
blood flow
cerebrospinal fluid flow
Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases