NCT01218191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

October 6, 2010

Last Update Submit

February 17, 2012

Conditions

Keywords

subarachnoid hemorrhagescintigraphyneurocardiogenic injury

Outcome Measures

Primary Outcomes (1)

  • cardiac 18F-FDG PET

    first week after SAH

Secondary Outcomes (3)

  • cardiac 123I-MIBG scintigraphy

    first week after SAH

  • cardiac 18F-FDG PET

    one month after first cardiac 18F-FDG PET

  • cardiac 123I-MIBG scintigraphy

    Six months after SAH

Study Arms (1)

Subarachnoid hemorrhage

Patients presenting a SAH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients presenting a SAH

You may qualify if:

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

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Military Teaching Hospital sainte Anne

Toulon, 83041, France

Location

Related Publications (3)

  • 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.

    PMID: 16286583BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric MEAUDRE, Professor

    Military Teaching Hospital Sainte Anne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,MSc

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 11, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations