Quantification of Cerebral Blood Flow by Arterial Spin Labeling in Vasospasm in Subarachnoid Haemorrhage

Subarachnoid Hemorrhage Clinical Trial

— ASL-HSA  

Official title:

Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557607
• Other study ID #: CHU-P 2013-06
• 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

• Hemorrhage
• Subarachnoid Hemorrhage

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