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Completed

NCT Number: NCT01218191

Acute Neurocardiogenic Injury After Subarachnoid Hemorrhage.

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit, Military Teaching Hospital sainte Anne

Toulon, 83041, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal of consent

Treatment and study plan

Primary outcomes

  1. cardiac 18F-FDG PET

    Time frame: first week after SAH

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Official study title

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

Acronym: HSA-2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2010
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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