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Trial record 48 of 195 for:    Hemorrhage AND SAH

Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage. (HSA-2)

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ClinicalTrials.gov Identifier: NCT01218191
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
PRUNET Bertrand, Direction Centrale du Service de Santé des Armées

Brief Summary:

The aim of this study is to describe acute neurocardiogenic injury after subarachnoid hemorrhage assessed with cardiac 123I-MIBG scintigraphy and 18F-FDG PET/CT during the first week and the first six months after SAH.

The study hypothesis is that the evolution of the cardiac disturbances follows the clinical evolution.


Condition or disease
Subarachnoid Hemorrhage

Detailed Description:

The cardiac metabolic disturbance are assessed by a 18F-FDG PET/CT in the first week after SAH and monthly until normal result.

The myocardial sympathetic innervation is assessed by a cardiac 123I-MIBG scintigraphy in the first week after SAH and six months later.

Clinical outcome is assessed by Glasgow Outcome Scale, modified Rankin Scale and MOS-SF36 at 1, 3 and 6 months after SAH.


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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Subarachnoid hemorrhage
Patients presenting a SAH



Primary Outcome Measures :
  1. cardiac 18F-FDG PET [ Time Frame: first week after SAH ]

Secondary Outcome Measures :
  1. cardiac 123I-MIBG scintigraphy [ Time Frame: first week after SAH ]
  2. cardiac 18F-FDG PET [ Time Frame: one month after first cardiac 18F-FDG PET ]
  3. cardiac 123I-MIBG scintigraphy [ Time Frame: Six months after SAH ]


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
Sampling Method:   Non-Probability Sample
Study Population
patients presenting a SAH
Criteria

Inclusion Criteria:

  • age
  • SAH
  • Hospitalization in the Military Teaching Hospital Sainte Anne

Exclusion Criteria:

  • Refusal of consent

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): NCT01218191


Locations
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France
Intensive Care Unit, Military Teaching Hospital sainte Anne
Toulon, France, 83041
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
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Study Director: Eric MEAUDRE, Professor Military Teaching Hospital Sainte Anne

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PRUNET Bertrand, MD,MSc, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT01218191     History of Changes
Other Study ID Numbers: HSA-2
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by PRUNET Bertrand, Direction Centrale du Service de Santé des Armées:
subarachnoid hemorrhage
scintigraphy
neurocardiogenic injury

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