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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00123695
Other study ID # 04-193
Secondary ID
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


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, 

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