Aneurysmal Subarachnoid HeamorrhageSAHHEARTNCT01670838
Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
An observational study of Aneurysmal Subarachnoid Heamorrhage and Nontraumatic Subarachnoid Haemorrhage, run by Kuopio University Hospital at 3 sites in 2 countries.
Trial summary
This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Heamorrhage, Nontraumatic Subarachnoid Haemorrhage
- How many people
- 198 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2012to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.
Who may be able to join
- Patients with nontraumatic subarachnoid haemorrhage
- Age > 18 years
- Aneurysmal bleeding
Who cannot join
- No consent
- Age < 18 years
- Anticipated brain death < 24 hours
- Otherwise moribund patient
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Kuopio University Hospital
Kuopio, PL 1777
Turku University Hospital
Turku, 20521
About this study
This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.
Read the detailed description
Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.
Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.
Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.
- Keywords
- subarachnoid haemorrhage, cardiopulmonary complications
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subarachnoid haemorrhage | nontraumatic subarachnoid haemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac failure and the impact of cardiac problems on morbidity
The aims of the study are:
- to document the incidence of myocardial dysfunction
- to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors
- to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography
- to describe heart rate variability
- to assess the impact of all cardiac problems on morbidity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HeamorrhageStudies of the same condition, open and under way.
- 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Principal investigator, Maarit Lang, Kuopio University Hospital
- Investigators
- Stepani Bendel, PhD, MD, Study director, Senior consultant, intensivistMaarit Lång, MD, Principal investigator, Senior consultant, intensivist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670838
- Sponsor's protocol ID
- Kuopio UH
- Acronym
- SAHHEART
- Status last verified
- Mar 2018
- First submitted
- 19 Aug 2012
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
- ClinicalTrials.gov ID
- NCT01670838
- Acronym / sponsor ID
- SAHHEART / Kuopio UH
- Keywords
- subarachnoid haemorrhage, cardiopulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- Feb 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Aug 2012 (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.
This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.
Detailed description
Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.
Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.
Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subarachnoid haemorrhage | – | –nontraumatic subarachnoid haemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.
Key inclusion criteria (3 listed)
- Patients with nontraumatic subarachnoid haemorrhage
- Age > 18 years
- Aneurysmal bleeding
Key exclusion criteria (4 listed)
- No consent
- Age < 18 years
- Anticipated brain death < 24 hours
- Otherwise moribund patient
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
Incidence of cardiac failure and the impact of cardiac problems on morbidity
Time frame: 6 months
The aims of the study are: 1. to document the incidence of myocardial dysfunction 2. to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors 3. to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography 4. to describe heart rate variability 5. to assess the impact of all cardiac problems on morbidity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No
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.
Stepani Bendel, PhD, MD study director
Senior consultant, intensivist
Maarit Lång, MD principal investigator
Senior consultant, intensivist
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Heamorrhage and Nontraumatic Subarachnoid Haemorrhage, run by Kuopio University Hospital at 3 sites in 2 countries.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Incidence of cardiac failure and the impact of cardiac problems on morbidity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2018.