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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02557607
Other study ID # CHU-P 2013-06
Secondary ID
Status Recruiting
Phase N/A
First received September 18, 2015
Last updated September 22, 2015
Start date December 2014
Est. completion date January 2018

Study information

Verified date September 2015
Source University Hospital, Angers
Contact Aram TER MINASSIAN, Physician
Phone 02.41.35.52.31
Email ArTerMinassian@chu-angers.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume


Description:

The subarachnoid hemorrhage (SAH) is a relatively severe disease whose prognosis is particularly related to the early onset of arterial vasospasm, maximum between the 5th and 14th day after SAH. Many obstacles make it difficult screening and monitoring of such complication. The challenge is to be able to demonstrate a reduction in regional cerebral blood flow before the onset of irreversible parenchymal sequelae, responsible for the majority of long-term morbidity among survivors. In clinical routine, screening vasospasm is achieved by Doppler intracranial arteries (DTC). However, its sensitivity is poor with regard to the middle and anterior cerebral arteries. The gold standard for diagnosis is cerebral arteriography. However, vasospasm in arteriography or trans-cranial Doppler does not prejudice the appearance of a delayed ischemic deficit.

A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults.

- Who have given their written consent.

- Affiliated to a social security system.

- Any patient hospitalized at the University Hospital of Angers in neurosurgical intensive care unit for supervision by ASL and DTC a subarachnoid hemorrhage from all etiologies (excluding traumatic).

Exclusion Criteria:

- Contraindications to MRI

- patient hospitalized at the University Hospital of Angers in surgical intensive care for monitoring a subarachnoid hemorrhage.

- patient hospitalized at the University Hospital of Angers for monitoring a subarachnoid hemorrhage traumatic.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
MRI
An analysis of the three sessions MRI performed systematically within the first 14 days of the start of symptoms revealing the HSA will be

Locations

Country Name City State
France CHU Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary exploitation of raw images provided with the waning of the acquisition of the sequence ASL. 15 days No
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