Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage.

Subarachnoid Hemorrhage Clinical Trial

— HSA-2  

Official title:

Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage Assessed With Cardiac 18F-FDG PET and 123I-MIBG Scintigraphy: a Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218191
• Other study ID #: HSA-2
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: February 17, 2012
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age

• SAH

• Hospitalization in the Military Teaching Hospital Sainte Anne

Exclusion Criteria:

• Refusal of consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
France	Intensive Care Unit, Military Teaching Hospital sainte Anne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Epub 2005 Nov 14. — View 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-cardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac 18F-FDG PET		first week after SAH	No
Secondary	cardiac 123I-MIBG scintigraphy		first week after SAH	No
Secondary	cardiac 18F-FDG PET		one month after first cardiac 18F-FDG PET	No
Secondary	cardiac 123I-MIBG scintigraphy		Six months after SAH	No