Serial Echocardiography After Subarachnoid Hemorrhage

• Conditions: Subarachnoid Hemorrhage; Myocardial Stunning; Takotsubo Cardiomyopathy

• Registration Number: NCT00123695
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief 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.

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-25
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-26
• Last Update Posted: 2008-03-27
• Primary Completion: 2008-06
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Erasmus Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands

Saint Elisabeth Hospital; 🇳🇱 Tilburg, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands