Clinical trial NCT00713375: Time Frequency Analysis of Electrocardiogram and Blood Pressure in Intracranial Hemorrhage Patients
Official title: Multiscale Entropy and Time-Frequency Analysis of Electrocardiogram and Blood Pressure in Patients With Spontaneous Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage
Keywords: Autonomic Nervous System
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spontaneous intracranial hemorrhage

Brief summary: Dysregulation of autonomic nervous system is evident in patients with spontaneous intracranial hemorrhage. In this study, we utilize a non-invasive method (heart rate and blood pressure variability analysis to analyze the autonomic activities in this group of neurosurgical patients. Our aim is to determine the utility of this modality in risk stratification and outcome prediction in these patients.

Detailed description: Spontaneous intracranial hemorrhage is an absolute emergency in the field of neurosurgery, and it is also a devastating event that commonly results in major neurological disabilities or mortalities. Since disease severities and clinical courses vary in each patient, pathophysiological studies and prognostic factors are always worth research. From previous studies, we know that dysregulation of autonomic system plays an important role in intracranial hemorrhage. Hemorrhage itself is associated with sympathoexcitation, and patients who develop rebleeding or infarction complications are found to have an even higher degree of sympathetic storm. Therefore, the degree of autonomic activities seems to be a useful predictor.

Traditionally, sympathetic activities are measured by plasma catecholamine, while parasympathetic activities are hard to measure. In recent decades, the application of engineering in biological fields makes a great breakthrough. Waveform analysis of biological signals, such as electrocardiograms and arterial blood pressure, can indirectly determine autonomic activities. The variabilities of heart rate and blood pressure are subjected to frequency analysis. This generates several dominant frequency bands. High frequency bands (0.15-0.40Hz) are attributed to the effect of parasympathetic nervous system, while, the low frequency bands (0.04-0.15 Hz) are attributed to the effect of both sympathetic and parasympathetic nervous systems.

In this study, all patients with spontaneous intracranial bleedings undergo standard treatment and monitoring. This include electrocardiography, arterial blood pressure, and cerebral blood flow using transcranial Doppler sonography. For those who also have intracranial pressure monitoring, the intracranial pressure are also recorded. All these biological signals are exported for wave form analysis. We use frequency analysis, time-frequency analysis, and multiscale entropy to analyze these data. The results of analyses were also correlated to plasma catecholamine levels, proinflammatory markers, as well as the clinical variables. Our aim is to identify predictors of complications and grave outcomes from these biological signals. We also apply the results for future pathophysiological studies.

Eligibility criteria: Inclusion Criteria:

* Spontaneous intracranial hemorrhage with radiographical confirmation

Exclusion Criteria:

* Traumatic or undefined mechanisms for intracranial hemorrhage
* Pre-existing cardiac arrythmia
* Patients who had previous histories of intracranial, cardiac, hepatic, renal, or lung diseases

Primary outcomes:
measure: Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability
timeFrame: 14 days within initial ictus
Secondary outcomes:
measure: Presence of vasospasm or not
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Devision of Neurosurgery, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yong-Kwang Tu, M.D.., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: