Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123695
Status:
UNKNOWN
Last Update Posted:
2008-03-27
First Post:
2005-07-21
Brief Title:
Serial Echocardiography After Subarachnoid Hemorrhage
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Serial Echocardiography After Subarachnoid Hemorrhage SEAS
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None