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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713375
Recruitment Status : Unknown
Verified July 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 11, 2008
Last Update Posted : July 11, 2008
Information provided by:
National Taiwan University Hospital

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.

Condition or disease
Subarachnoid Hemorrhage Intracranial Hemorrhages Cerebral Hemorrhage

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.

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Primary Outcome Measures :
  1. Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability [ Time Frame: 14 days within initial ictus ]

Secondary Outcome Measures :
  1. Presence of vasospasm or not [ Time Frame: 14 weeks ]

Biospecimen Retention:   Samples With DNA
Whole blood. Cerebral spinal fluids

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spontaneous intracranial hemorrhage

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713375

Contact: Kuo-Chuan Wang, M.D. 886-2-23123456 ext 5077

Department of Surgery, National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 112
Contact: Yong-Kwang Tu, MD, PhD    886-2-23123456 ext 5078   
Devision of Neurosurgery, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 112
Contact: Kuo-chuan wang, MD    886223123456 ext 5077   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Yong-Kwang Tu, M.D.., Ph.D National Taiwan University Hospital

Responsible Party: Kuo-Chuan Wang, MD, National Taiwan University Hospital Identifier: NCT00713375     History of Changes
Other Study ID Numbers: 200803013R
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: July 11, 2008
Last Verified: July 2008

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

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