- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713375
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
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kuo-Chuan Wang, M.D.
- Phone Number: 5077 886-2-23123456
- Email: wang081466@yahoo.com.tw
Study Locations
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-
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Taipei, Taiwan, 112
- Recruiting
- Devision of Neurosurgery, National Taiwan University Hospital
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Contact:
- Kuo-chuan wang, MD
- Phone Number: 5077 886223123456
- Email: wang081466@yahoo.com.tw
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Taipei, Taiwan, 112
- Not yet recruiting
- Department of Surgery, National Taiwan University Hospital
-
Contact:
- Yong-Kwang Tu, MD, PhD
- Phone Number: 5078 886-2-23123456
- Email: yktu@ntuh.gov.tw
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Activity of autonomic nervous activities determined by low frequency and high frequency energies in heart rate variability
Time Frame: 14 days within initial ictus
|
14 days within initial ictus
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of vasospasm or not
Time Frame: 14 weeks
|
14 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yong-Kwang Tu, M.D.., Ph.D, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200803013R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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