Pathological Conditions, AnatomicalNCT00173238
The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography
An observational study of Pathological Conditions, Anatomical, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pathological Conditions, Anatomical
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jun 2008
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Heart transplantation, atherosclerosis
Who cannot join
- Infection
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Nai-Kuan Chou, MD.,PhD, 886-2-23123456 ext. 5066, nickchou@ha.mc.ntu.edu.tw
Nai-Kuan Chou, MD.,PhD
About this study
Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events.
Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on low coherence interferometry. It is analogous to ultrasound imaging except that it uses infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT) combines the advantages of OCT with additional image contrast of the sample. The added contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously.
The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT image criteria for atherosclerotic plaque characterization in vitro.
Read the detailed description
Optical Coherence Tomography (OCT) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. OCT combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. Whereas ultrasound produces images from backscattered sound "echoes," OCT uses infrared light waves that reflect off the internal microstructure within the biological tissues.
- Conditions
- Pathological Conditions, Anatomical
- Keywords
- atherosclerosis, optical coherence tomography, polarization, phase retardation, birefringence
- Medical subject headings
- Pathological Conditions, Anatomical, Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological Conditions, AnatomicalStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nai-Kuan Chou, MD.,PhD, Principal investigator, National Taiwan University Hospital,Taipei.Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173238
- Sponsor's protocol ID
- 9461700533
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00173238
- Acronym / sponsor ID
- 9461700533
- Conditions
- Pathological Conditions, Anatomical
- Keywords
- atherosclerosis, optical coherence tomography, polarization, phase retardation, birefringence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jun 2008
- First posted
- 15 Sep 2005 (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.
Atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. Rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. Therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events.
Optical coherence tomography (OCT) is a powerful tool capable of tomographic imaging based on low coherence interferometry. It is analogous to ultrasound imaging except that it uses infrared light instead of sound. Polarization-sensitive optical coherence tomography (PS-OCT) combines the advantages of OCT with additional image contrast of the sample. The added contrast is based on the ability of PS-OCT to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously.
The goals of this project are: 1) to examine whether PS-OCT is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative PS-OCT image criteria for atherosclerotic plaque characterization in vitro.
Detailed description
Optical Coherence Tomography (OCT) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. OCT combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. Whereas ultrasound produces images from backscattered sound "echoes," OCT uses infrared light waves that reflect off the internal microstructure within the biological tissues.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Heart transplantation, atherosclerosis
Key exclusion criteria (1 listed)
- Infection
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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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.
Nai-Kuan Chou, MD.,PhD principal investigator
National Taiwan University Hospital,Taipei.Taiwan
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 Pathological Conditions, Anatomical, 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 1 inclusion and 1 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 21 Dec 2005. 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 Nai-Kuan Chou, MD.,PhD (886-2-23123456 ext. 5066, nickchou@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Dec 2005.