- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557607
Quantification of Cerebral Blood Flow by Arterial Spin Labeling in Vasospasm in Subarachnoid Haemorrhage (ASL-HSA)
Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage
Study Overview
Detailed 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aram TER MINASSIAN, Physician
- Phone Number: 33 02.41.35.52.31
- Email: ArTerMinassian@chu-angers.fr
Study Locations
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-
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Angers, France, 49933
- Recruiting
- CHU Angers
-
Contact:
- Aram TER MINASSIAN, Physician
- Phone Number: 33 02.41.35.52.31
- Email: ArTerMinassian@chu-angers.fr
-
Principal Investigator:
- Aram TER MINASSIAN, Physician
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Monitoring a subarachnoid hemorrhage
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).
An analysis of the three sessions MRI performed systematically within the first 14 days of the start of symptoms revealing the HSA will be
|
An analysis of the three sessions MRI performed systematically within the first 14 days of the start of symptoms revealing the HSA will be
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
exploitation of raw images provided with the waning of the acquisition of the sequence ASL.
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aram TER MINASSIAN, Physician, UH Angers
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-P 2013-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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