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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Taiwan University Hospital

July 9, 2008
July 11, 2008
July 11, 2008
April 2008
April 2008   (Final data collection date for primary outcome measure)
Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability [ Time Frame: 14 days within initial ictus ]
Same as current
No Changes Posted
Presence of vasospasm or not [ Time Frame: 14 weeks ]
Same as current
Not Provided
Not Provided
 
Time Frequency Analysis of Electrocardiogram and Blood Pressure in Intracranial Hemorrhage Patients
Multiscale Entropy and Time-Frequency Analysis of Electrocardiogram and Blood Pressure in Patients With Spontaneous Intracranial Hemorrhage
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood. Cerebral spinal fluids
Non-Probability Sample
Patients with spontaneous intracranial hemorrhage
  • Subarachnoid Hemorrhage
  • Intracranial Hemorrhages
  • Cerebral Hemorrhage
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
Same as current
Not Provided
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00713375
200803013R
Yes
Not Provided
Not Provided
Kuo-Chuan Wang, MD, National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Yong-Kwang Tu, M.D.., Ph.D National Taiwan University Hospital
National Taiwan University Hospital
July 2008