Time Frequency Analysis of Electrocardiogram and Blood Pressure in Intracranial Hemorrhage Patients

Subarachnoid Hemorrhage Clinical Trial

Official title:

Multiscale Entropy and Time-Frequency Analysis of Electrocardiogram and Blood Pressure in Patients With Spontaneous Intracranial Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00713375
• Other study ID #: 200803013R
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 10, 2008
• Start date: April 2008

Study information

• Verified date: July 2008
• Source: National Taiwan University Hospital
• Contact: Kuo-Chuan Wang, M.D.
• Phone: 886-2-23123456
• Email: wang081466[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
Taiwan	Department of Surgery, National Taiwan University Hospital	Taipei
Taiwan	Devision of Neurosurgery, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability		14 days within initial ictus	No
Secondary	Presence of vasospasm or not		14 weeks	No