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Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)
This study is ongoing, but not recruiting participants.
Study NCT00123695   Information provided by VU University Medical Center
First Received: July 21, 2005   Last Updated: March 26, 2008   History of Changes

July 21, 2005
March 26, 2008
May 2005
June 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00123695 on ClinicalTrials.gov Archive Site
 
 
 
Serial Echocardiography After Subarachnoid Hemorrhage
Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)

There is increasing interest in myocardial abnormalities following central nervous system events, such as subarachnoid hemorrhage (SAH). These cardiac abnormalities include ECG changes, decreased cardiac output, decreased blood pressure, specific cardiac enzyme elevations, and segmental wall motion abnormalities (SWMA). Interestingly, wall motion abnormalities and ECG changes have shown to be reversible, and therefore the dysfunction has been described as neurogenic myocardial stunning.

The pathophysiology of cardiac dysfunction following SAH has not yet been fully elucidated. Many reports (mainly case reports) have been published, but so far no study has investigated the frequency of these abnormalities in a prospective manner, have correlated the occurrence of the different cardiac abnormalities, and have assessed which clinical variables can predict cardiac dysfunction. And only a limited number of studies have related neurological outcome with cardiac dysfunction.

Objectives: Therefore, our study objectives are: 1) Assessment of the frequency of myocardial dysfunction (segmental wall motion abnormalities, cardiac-specific enzyme elevations, and ECG changes) in patients with SAH. 2) Determination of predictive clinical variables for the occurrence of myocardial dysfunction following SAH. 3) Impact of myocardial dysfunction on neurological prognosis: death, secondary cerebral ischemia, hydrocephalus and rebleeding.

Methods: For this purpose serial echocardiograms and ECGs will be obtained and cardiac enzymes will be measured in 200-400 patients admitted to hospital with SAH in the four participating centers. The clinical variables that will be studied to predict cardiac dysfunction are: medical history, the CT-scan score, circulatory parameters, blood samples, medication, surgical intervention (coiling or clipping), and the neurological condition (Glasgow Coma Scale). The echocardiograms, ECGs and cardiac enzymes will be studied to determine if they have independent prognostic value for the outcome in SAH patients.

Expected Results: As ECG changes and drops in blood pressure are known to occur frequently, the researchers expect to find that cardiac contractile dysfunction in patients with SAH occurs more frequently than is assumed now. Moreover, if cardiac abnormalities have neurological prognostic significance further studies are needed for early recognition and treatment of the cardiac abnormalities in SAH, a condition with a very poor prognosis.

 
Observational
Cohort, Prospective
  • Subarachnoid Hemorrhage
  • Myocardial Stunning
  • Takotsubo Cardiomyopathy
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
350
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with aneurysmal subarachnoid hemorrhage
  • Admitted within 72 hours of the bleed

Exclusion Criteria:

  • No informed consent
  • Patients or patients' family unwillingness to participate
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00123695
 
04-193
VU University Medical Center
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • UMC Utrecht
  • University Medical Centre Groningen
  • Erasmus Medical Center
Principal Investigator: Frans C Visser, MD PhD VU University Medical Center
Study Director: Ivo A van der Bilt, MD Academic Medical Center Amsterdam
Principal Investigator: Gabriel J Rinkel, MD PhD University Medical Center Utrecht
Principal Investigator: Arthur A Wilde, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP