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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00713375
First received: July 9, 2008
Last updated: July 10, 2008
Last verified: July 2008
  Purpose

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.


Condition
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multiscale Entropy and Time-Frequency Analysis of Electrocardiogram and Blood Pressure in Patients With Spontaneous Intracranial Hemorrhage

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability [ Time Frame: 14 days within initial ictus ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of vasospasm or not [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood. Cerebral spinal fluids


Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with spontaneous intracranial hemorrhage

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713375

Contacts
Contact: Kuo-Chuan Wang, M.D. 886-2-23123456 ext 5077 wang081466@yahoo.com.tw

Locations
Taiwan
Department of Surgery, National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 112
Contact: Yong-Kwang Tu, MD, PhD    886-2-23123456 ext 5078    yktu@ntuh.gov.tw   
Devision of Neurosurgery, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 112
Contact: Kuo-chuan wang, MD    886223123456 ext 5077    wang081466@yahoo.com.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yong-Kwang Tu, M.D.., Ph.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Kuo-Chuan Wang, MD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00713375     History of Changes
Other Study ID Numbers: 200803013R
Study First Received: July 9, 2008
Last Updated: July 10, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Autonomic Nervous System
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014