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.

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Key information

Conditions

Aneurysmal Subarachnoid Heamorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Nontraumatic Subarachnoid Haemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kuopio University Hospital, Kuopio, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of cardiac failure and the impact of cardiac problems on morbidity

Time frame: 6 months
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

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

Turku University Hospital

Registry information

Acronym: SAHHEART

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Aug 22, 2012
Registry last updated: Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed