Serial Echocardiography After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— SEAS  

Official title:

Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00123695
• Other study ID #: 04-193
• Status: Active, not recruiting
• Phase: N/A
• First received: July 21, 2005
• Last updated: March 26, 2008
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2008
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Hemorrhage
• Myocardial Stunning
• Subarachnoid Hemorrhage
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	NH
Netherlands	Academic Medical Center	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Erasmus Medical Center Rotterdam	Rotterdam
Netherlands	Saint Elisabeth Hospital	Tilburg
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
VU University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, UMC Utrecht, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands,