Subarachnoid HemorrhageSEASNCT00123695
Serial Echocardiography After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Myocardial Stunning, run by Amsterdam UMC, location VUmc at 6 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Myocardial Stunning, Takotsubo Cardiomyopathy
- How many people
- 350 participants
- Where
- 6 sitesNetherlands
- Study dates
- May 2005to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with aneurysmal subarachnoid hemorrhage
- Admitted within 72 hours of the bleed
Who cannot join
- No informed consent
- Patients or patients' family unwillingness to participate
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Academic Medical Center
Amsterdam, 1105 AZ
University Medical Center Groningen
Groningen, 9700 RB
Erasmus Medical Center Rotterdam
Rotterdam
Saint Elisabeth Hospital
Tilburg, 5022 GC
University Medical Center Utrecht
Utrecht
About this study
Official title: Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)
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.
Read the 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.
- Keywords
- Subarachnoid hemorrhage, Takotsubo cardiomyopathy, Cardiac abnormalities, outcome
- Medical subject headings
- Subarachnoid Hemorrhage, Myocardial Stunning, Takotsubo Cardiomyopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, University Medical Center Groningen, Erasmus Medical Center
- Investigators
- Frans C Visser, MD PhD, Principal investigator, Amsterdam UMC, location VUmcIvo A van der Bilt, MD, Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Gabriel J Rinkel, MD PhD, Principal investigator, UMC UtrechtArthur A Wilde, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123695
- Sponsor's protocol ID
- 04-193
- Acronym
- SEAS
- Status last verified
- Mar 2008
- First submitted
- 21 Jul 2005
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Bilt IA, Hasan D, van den Brink RB, Cramer MJ, van der Jagt M, van Kooten F, Regtien JG, van den Berg MP, Groen RJ, Cate FJ, Kamp O, Gotte MJ, Horn J, Girbes AR, Vandertop WP, Algra A, Rinkel GJ, Wilde AA; SEASAH (Serial Echocardiography After Subarachnoid Hemorrhage) Investigators. Time course and risk factors for myocardial dysfunction after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2015 Jun;76(6):700-5; discussion 705-6. doi: 10.1227/NEU.0000000000000699.
PubMed 25714519
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)
- ClinicalTrials.gov ID
- NCT00123695
- Acronym / sponsor ID
- SEAS / 04-193
- Keywords
- Subarachnoid hemorrhage, Takotsubo cardiomyopathy, Cardiac abnormalities, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, University Medical Center Groningen, Erasmus Medical Center
- Study start
- May 2005
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with aneurysmal subarachnoid hemorrhage
- Admitted within 72 hours of the bleed
Key exclusion criteria (2 listed)
- No informed consent
- Patients or patients' family unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
- Derived from this study: PubMed 25714519van der Bilt IA, Hasan D, van den Brink RB, Cramer MJ, van der Jagt M, van Kooten F, Regtien JG, van den Berg MP, Groen RJ, Cate FJ, Kamp O, Gotte MJ, Horn J, Girbes AR, Vandertop WP, Algra A, Rinkel GJ, Wilde AA; SEASAH (Serial Echocardiography After Subarachnoid Hemorrhage) Investigators. Time course and risk factors for myocardial dysfunction after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2015 Jun;76(6):700-5; discussion 705-6. doi: 10.1227/NEU.0000000000000699.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans C Visser, MD PhD principal investigator
Amsterdam UMC, location VUmc
Ivo A van der Bilt, MD study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Gabriel J Rinkel, MD PhD principal investigator
UMC Utrecht
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Myocardial Stunning, run by Amsterdam UMC, location VUmc at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.