Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients (SAHHEART)

This study is currently recruiting participants.
Verified November 2013 by Kuopio University Hospital
Sponsor:
Collaborator:
Turku University Hospital
Information provided by (Responsible Party):
Maarit Lang, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01670838
First received: August 19, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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
Aneurysmal Subarachnoid Heamorrhage
Nontraumatic Subarachnoid Haemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Incidence of cardiac failure and the impact of cardiac problems on morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
subarachnoid haemorrhage
nontraumatic subarachnoid haemorrhage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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   
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

No publications provided

Responsible Party: Maarit Lang, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01670838     History of Changes
Other Study ID Numbers: Kuopio UH
Study First Received: August 19, 2012
Last Updated: November 5, 2013
Health Authority: Finland: TUKIJA

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014