Advanced Analysis of the Carotid Phonoangiography and Diseases

January 29, 2014 updated by: National Taiwan University Hospital

Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its relationship to the vessel disease, and to build a new biomarker about vascular disorder.

Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The results will be correlated and comparison to the finding in clinical, carotid Doppler and duplex, CTA, MR, and catheter angiography.

Statistics:

The significance of difference between parameters was computed using t-tests or paired t-test etc. A p value <0.05 is defined as significant.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators plan to recruit data from patients that come to their department for angiography study and intervention (n=300) with different disease entity such as atherosclerosis, tumor, aneurysm, arteriovenous malformation or fistula, and other vascular disorders. A period of about 20 seconds of the carotid phonoangiography was recorded.

Standard for comparison: catheter angiography, CTA, MRI/MRA. The degree of stenosis, the wall thickness, SI and density change was clustered and compared. The clinical and laboratory data will be reviewed and the vascular risk factors will be calculated.

Spectrum analysis: The sound spectrum will be analysis with the FFT, wavelet, entropy, complexity, and HHT algorithms.

The correlation between change of spectrums and also the correlated clinical, images, and laboratory change will be further analysis by statistic method.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taiwan, Taiwan, 10002
        • Hon-Man Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the patients who is going to have carotid angiography study and with informed consent signed.

Description

Inclusion Criteria:

  1. Age: 20 years old to 99 years old
  2. Gender: Unlimited
  3. Because different types of brain diseases, those who received conventional catheter vascular examination.

Exclusion Criteria:

  1. Neck inflammation locally who can not admit the sound.
  2. Due to inability to cooperate to accept those recordings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression of stenosis
Time Frame: three years
Follow-up the severity of the carotid stenosis and correlate its wall change
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wall change
Time Frame: three years
correlate the phonographic change with the follow up CTA wall change.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hon-Man Liu, MD, MBA, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201311042RIND

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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