Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)
Recruitment status was Active, not recruiting
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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.) |
| 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.
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| 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 | 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 May 16, 2013