Clinical trial NCT01218191: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage.
Official title: Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage
scintigraphy
neurocardiogenic injury
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting a SAH

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: cardiac 18F-FDG PET
timeFrame: first week after SAH
Secondary outcomes:
measure: cardiac 123I-MIBG scintigraphy
timeFrame: first week after SAH
measure: cardiac 18F-FDG PET
timeFrame: one month after first cardiac 18F-FDG PET
measure: cardiac 123I-MIBG scintigraphy
timeFrame: Six months after SAH
Other outcomes:
Locations:
city: Toulon
country: France
facility: Intensive Care Unit, Military Teaching Hospital sainte Anne
Study officials:
affiliation: Military Teaching Hospital Sainte Anne
name: Eric MEAUDRE, Professor
role: STUDY_DIRECTOR
References:
citation: Banki NM, Kopelnik A, Dae MW, Miss J, Tung P, Lawton MT, Drew BJ, Foster E, Smith W, Parmley WW, Zaroff JG. Acute neurocardiogenic injury after subarachnoid hemorrhage. Circulation. 2005 Nov 22;112(21):3314-9. doi: 10.1161/CIRCULATIONAHA.105.558239. Epub 2005 Nov 14.
citation: Meaudre E, Jego C, Kenane N, Montcriol A, Boret H, Goutorbe P, Habib G, Palmier B. B-type natriuretic peptide release and left ventricular filling pressure assessed by echocardiographic study after subarachnoid hemorrhage: a prospective study in non-cardiac patients. Crit Care. 2009;13(3):R76. doi: 10.1186/cc7891. Epub 2009 May 20.
citation: Prunet B, Basely M, D'Aranda E, Cambefort P, Pons F, Cimarelli S, Dagain A, Desse N, Veyrieres JB, Jego C, Lacroix G, Esnault P, Boret H, Goutorbe P, Bussy E, Habib G, Meaudre E. Impairment of cardiac metabolism and sympathetic innervation after aneurysmal subarachnoid hemorrhage: a nuclear medicine imaging study. Crit Care. 2014 Jun 25;18(3):R131. doi: 10.1186/cc13943.