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The Study of Human Atherosclerosis by Polarization-Sensitive Optical Coherence Tomography

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173238
First Posted: September 15, 2005
Last Update Posted: December 21, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

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.


Condition
Pathological Conditions, Anatomical

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 5
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart transplantation, atherosclerosis

Exclusion Criteria:

  • Infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173238


Contacts
Contact: Nai-Kuan Chou, MD.,PhD 886-2-23123456 ext 5066 nickchou@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Nai-Kuan Chou, MD.,PhD    886-2-23123456 ext 5066    nickchou@ha.mc.ntu.edu.tw   
Principal Investigator: Nai-Kuan Chou, MD.,PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Nai-Kuan Chou, MD.,PhD National Taiwan University Hospital,Taipei.Taiwan
  More Information

ClinicalTrials.gov Identifier: NCT00173238     History of Changes
Other Study ID Numbers: 9461700533
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 21, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
atherosclerosis
optical coherence tomography
polarization
phase retardation
birefringence

Additional relevant MeSH terms:
Atherosclerosis
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases