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Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
University Medical Centre Groningen
Erasmus Medical Center
Information provided by: VU University Medical Center
ClinicalTrials.gov Identifier: NCT00123695
  Purpose

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
Subarachnoid Hemorrhage
Myocardial Stunning
Takotsubo Cardiomyopathy

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)

Further study details as provided by VU University Medical Center:

Estimated Enrollment: 350
Study Start Date: May 2005
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123695

Locations
Netherlands
Saint Elisabeth Hospital
Tilburg, Netherlands, 5022 GC
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
University Medical Center Utrecht
Utrecht, Netherlands
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
Netherlands, NH
Academic Medical Center
Amsterdam, NH, Netherlands, 1105AZ
Sponsors and Collaborators
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
University Medical Centre Groningen
Erasmus Medical Center
Investigators
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)
  More Information

Study ID Numbers: 04-193
Study First Received: July 21, 2005
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00123695  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Subarachnoid hemorrhage
Takotsubo cardiomyopathy
Cardiac abnormalities
outcome

Study placed in the following topic categories:
Ventricular Dysfunction
Myocardial Stunning
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Diseases
Ischemia
Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Cardiomyopathies
Cerebrovascular Disorders
Takotsubo Cardiomyopathy
Tako-Tsubo syndrome
Subarachnoid Hemorrhage
Ventricular Dysfunction, Left
Congenital Abnormalities
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009