Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Aneurysmal Subarachnoid Heamorrhage Clinical Trial

— SAHHEART  

Official title:

Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670838
• Other study ID #: Kuopio UH
• Status: Completed
• Phase: N/A
• First received: August 19, 2012
• Last updated: March 14, 2018
• Start date: February 2012
• Est. completion date: August 2017

Study information

• Verified date: March 2018
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 variability and to assess the impact of all cardiac problems on morbidity and mortality.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Heamorrhage
• Hemorrhage
• Nontraumatic Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Turku University Hospital	Turku
Switzerland	Inselspital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	Turku University Hospital

Countries where clinical trial is conducted

Finland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months