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Quantification of Cerebral Blood Flow by Arterial Spin Labeling in Vasospasm in Subarachnoid Haemorrhage (ASL-HSA)

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ClinicalTrials.gov Identifier: NCT02557607
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Device: MRI Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. exploitation of raw images provided with the waning of the acquisition of the sequence ASL. [ Time Frame: 15 days ]


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:   No
Criteria

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.

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): NCT02557607


Contacts
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Contact: Aram TER MINASSIAN, Physician 02.41.35.52.31 ext 33 ArTerMinassian@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Aram TER MINASSIAN, Physician    02.41.35.52.31 ext 33    ArTerMinassian@chu-angers.fr   
Principal Investigator: Aram TER MINASSIAN, Physician         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Aram TER MINASSIAN, Physician UH ANGERS
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02557607    
Other Study ID Numbers: CHU-P 2013-06
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases