Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by VU University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: July 21, 2005
Last updated: March 26, 2008
Last verified: March 2008
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
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
Rotterdam, Netherlands
Saint Elisabeth Hospital
Tilburg, Netherlands, 5022 GC
University Medical Center Utrecht
Utrecht, Netherlands
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 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)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00123695     History of Changes
Other Study ID Numbers: 04-193
Study First Received: July 21, 2005
Last Updated: March 26, 2008
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

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Myocardial Stunning
Cardiomyopathies
Takotsubo Cardiomyopathy
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction

ClinicalTrials.gov processed this record on July 26, 2014