Carotid AtherosclerosisNCT02049463
Advanced Analysis of the Carotid Phonoangiography and Diseases
An observational study of Carotid Atherosclerosis and Seeing Sounds as Colors, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Carotid Atherosclerosis, Seeing Sounds as Colors, Stenosis
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who is going to have carotid angiography study and with informed consent signed.
Who may be able to join
- Age: 20 years old to 99 years old
- Gender: Unlimited
- Because different types of brain diseases, those who received conventional catheter vascular examination.
Who cannot join
- Neck inflammation locally who can not admit the sound.
- Due to inability to cooperate to accept those recordings.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Hon-Man Liu
Dawan, Taiwan, 10002
Hon-Man Liu, MD, MBA, 886-2-23123456 ext. 70329, hmliu@ntu.edu.tw
Hon-Man Liu, MD, MBA
About this study
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.
Read the 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.
- Conditions
- Carotid Atherosclerosis, Seeing Sounds as Colors, Stenosis, Stroke
- Keywords
- carotid artery, sound, stenosis, wall, stroke
- Medical subject headings
- Carotid Artery Diseases, Constriction, Pathologic, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of stenosis
Follow-up the severity of the carotid stenosis and correlate its wall change
Measured: three years
Secondary outcomes (1)
wall change
correlate the phonographic change with the follow up CTA wall change.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Hon-man Liu, MD, MBA, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049463
- Sponsor's protocol ID
- 201311042RIND
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2014
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Analysis of the Carotid Phonoangiography and Diseases
- ClinicalTrials.gov ID
- NCT02049463
- Acronym / sponsor ID
- 201311042RIND
- Conditions
- Carotid Atherosclerosis, Seeing Sounds as Colors, Stenosis, Stroke
- Keywords
- carotid artery, sound, stenosis, wall, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who is going to have carotid angiography study and with informed consent signed.
Key inclusion criteria (3 listed)
- Age: 20 years old to 99 years old
- Gender: Unlimited
- Because different types of brain diseases, those who received conventional catheter vascular examination.
Key exclusion criteria (2 listed)
- Neck inflammation locally who can not admit the sound.
- Due to inability to cooperate to accept those recordings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression of stenosis
Time frame: three years
Follow-up the severity of the carotid stenosis and correlate its wall change
1 secondary outcome
wall change
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon-man Liu, MD, MBA principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis and Seeing Sounds as Colors, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hon-man Liu, MD, MBA (886-2-23123456 ext. 70329, hmliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of stenosis (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.