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Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients (SAHHEART)

This study is currently recruiting participants.
Verified March 2017 by Maarit Lang, Kuopio University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01670838
First Posted: August 22, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Turku University Hospital
Information provided by (Responsible Party):
Maarit Lang, Kuopio University Hospital
August 19, 2012
August 22, 2012
March 3, 2017
February 2012
August 2017   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01670838 on ClinicalTrials.gov Archive Site
Not Provided
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Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
MICRORNA
Non-Probability Sample
Study material consists of 200 consecutive aSAH-patients treated in Kuopio University Hospital and Turku University Hospital.
  • Aneurysmal Subarachnoid Heamorrhage
  • Nontraumatic Subarachnoid Haemorrhage
Not Provided
subarachnoid haemorrhage
nontraumatic subarachnoid haemorrhage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2017
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Maarit Lång, MD +35817173430 maarit.lang@kuh.fi
Contact: Stepani Bendel, PhD, MD +35817173430 stepani.bendel@kuh.fi
Finland,   Switzerland
 
 
NCT01670838
Kuopio UH
Yes
Not Provided
Plan to Share IPD: No
Maarit Lang, Kuopio University Hospital
Kuopio University Hospital
Turku University Hospital
Study Director: Stepani Bendel, PhD, MD Senior consultant, intensivist
Principal Investigator: Maarit Lång, MD Senior consultant, intensivist
Kuopio University Hospital
March 2017