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Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients (SAHHEART)

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ClinicalTrials.gov Identifier: NCT01670838
Recruitment Status : Recruiting
First Posted : August 22, 2012
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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 variability and to assess the impact of all cardiac problems on morbidity and mortality.

Condition or disease
Aneurysmal Subarachnoid Heamorrhage Nontraumatic Subarachnoid Haemorrhage

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

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
Study Start Date : February 2012
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
subarachnoid haemorrhage
nontraumatic subarachnoid haemorrhage


Outcome Measures

Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
MICRORNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.
Criteria

Inclusion Criteria:

  • Patients with nontraumatic subarachnoid haemorrhage
  • Age > 18 years
  • Aneurysmal bleeding

Exclusion Criteria:

  • No consent
  • Age < 18 years
  • Anticipated brain death < 24 hours
  • Otherwise moribund patient
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670838


Contacts
Contact: Maarit Lång, MD +35817173430 maarit.lang@kuh.fi
Contact: Stepani Bendel, PhD, MD +35817173430 stepani.bendel@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, PL 1777
Contact: Maarit Lång, MD    +35817173430    maarit.lang@kuh.fi   
Turku University Hospital Not yet recruiting
Turku, Finland, 20521
Contact: Riikka Takala, PhD, MD       riikka.takala@tyks.fi   
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland
Contact: Jukka Takala, Professor         
Principal Investigator: Jukka Takala, Professor         
Sponsors and Collaborators
Kuopio University Hospital
Turku University Hospital
Investigators
Study Director: Stepani Bendel, PhD, MD Senior consultant, intensivist
Principal Investigator: Maarit Lång, MD Senior consultant, intensivist
More Information

Responsible Party: Maarit Lang, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01670838     History of Changes
Other Study ID Numbers: Kuopio UH
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maarit Lang, Kuopio University Hospital:
subarachnoid haemorrhage
cardiopulmonary complications

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases