Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients (SAHHEART)

This study is currently recruiting participants.

Verified April 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: April 11, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2012

Last Updated Date

April 11, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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:

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01670838 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Official Title ^ICMJE

Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.

Condition ^ICMJE

Aneurysmal Subarachnoid Heamorrhage
Nontraumatic Subarachnoid Haemorrhage

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

subarachnoid haemorrhage

nontraumatic subarachnoid haemorrhage

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

November 2015

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01670838

Other Study ID Numbers ^ICMJE

Kuopio UH

Has Data Monitoring Committee

Yes

Responsible Party

Maarit Lang, Kuopio University Hospital

Study Sponsor ^ICMJE

Kuopio University Hospital

Collaborators ^ICMJE

Turku University Hospital

Investigators ^ICMJE

Study Director:	Stepani Bendel, PhD, MD	Senior consultant, intensivist
Principal Investigator:	Maarit Lång, MD	Senior consultant, intensivist

Information Provided By

Kuopio University Hospital

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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