Advanced Analysis of the Carotid Phonoangiography and Diseases

Stroke Clinical Trial

Official title:

Advanced Analysis of the Carotid Phonoangiography and Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02049463
• Other study ID #: 201311042RIND
• Status: Not yet recruiting
• Phase: N/A
• First received: January 28, 2014
• Last updated: January 29, 2014
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2014
• Source: National Taiwan University Hospital
• Contact: Hon-man Liu, MD, MBA
• Phone: 886-2-23123456
• Email: hmliu[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Seeing Sounds as Colors
• Stenosis
• Stroke

Locations

Country	Name	City	State
Taiwan	Hon-Man Liu	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression of stenosis	Follow-up the severity of the carotid stenosis and correlate its wall change	three years	No
Secondary	wall change	correlate the phonographic change with the follow up CTA wall change.	three years	No