Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)
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|ClinicalTrials.gov Identifier: NCT00123695|
Recruitment Status : Unknown
Verified March 2008 by VU University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2005
Last Update Posted : March 27, 2008
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.
|Condition or disease|
|Subarachnoid Hemorrhage Myocardial Stunning Takotsubo Cardiomyopathy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||June 2008|
|Estimated Study Completion Date :||June 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123695
|Academic Medical Center|
|Amsterdam, NH, Netherlands, 1105AZ|
|Academic Medical Center|
|Amsterdam, Netherlands, 1105 AZ|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Erasmus Medical Center Rotterdam|
|Saint Elisabeth Hospital|
|Tilburg, Netherlands, 5022 GC|
|University Medical Center Utrecht|
|Principal Investigator:||Frans C Visser, MD PhD||VU University Medical Center|
|Study Director:||Ivo A van der Bilt, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Gabriel J Rinkel, MD PhD||UMC Utrecht|
|Principal Investigator:||Arthur A Wilde, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|