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Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

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StatusRecrutamento
Patrocinadores
Centre Hospitalier Universitaire, Amiens

Palavras-chave

Resumo

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.

Descrição

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.

datas

Última verificação: 01/31/2020
Enviado pela primeira vez: 10/02/2019
Inscrição estimada enviada: 10/02/2019
Postado pela primeira vez: 10/03/2019
Última atualização enviada: 02/24/2020
Última atualização postada: 02/25/2020
Data real de início do estudo: 02/18/2020
Data Estimada de Conclusão Primária: 09/30/2022
Data Estimada de Conclusão do Estudo: 09/30/2022

Condição ou doença

Intracranial Hypertension

Intervenção / tratamento

Diagnostic Test: MRI examination

Diagnostic Test: ECG

Fase

-

Grupos de Armas

BraçoIntervenção / tratamento
Experimental: idiopathic intracranial hypertension
patients with idiopathic intracranial hypertension
Sham Comparator: healthy subjects
Healthy subjects

Critério de eleição

Idades qualificadas para estudar 18 Years Para 18 Years
Sexos elegíveis para estudoAll
Aceita Voluntários Saudáveissim
Critério

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

Resultado

Medidas de Resultado Primário

1. Ratio between jugular vein flow and total arterial brain flow. [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.

Medidas de Resultado Secundário

1. CSF (cerebrospinal fluid) Stroke volumes [day 0 = day of inclusion]

CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels

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