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Sponsors and Collaborators: |
VU University Medical Center Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) UMC Utrecht University Medical Centre Groningen Erasmus Medical Center |
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Information provided by: | VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT00123695 |
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 |
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Subarachnoid Hemorrhage Myocardial Stunning Takotsubo Cardiomyopathy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.) |
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) |
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.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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) |
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) |
Subarachnoid hemorrhage Takotsubo cardiomyopathy Cardiac abnormalities outcome |
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 |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |