Invasive Measurement of Axial Plaque Stress, the Pilot Study
NCT ID: NCT02388399
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-03-31
2018-03-31
Brief Summary
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In addition, the investigators will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.
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Detailed Description
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Recently, we evaluated the axial plaque stress, which is axial component of total traction acting on the plaque, and showed that the axial plaque stress possess significantly higher magnitude than previously known wall shear stress.
However, the axial plaque stress in our previous research was measured with computational flow dynamics analysis using coronary artery model from coronary CT angiography.
In this study, we sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.
In addition, we will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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OCT and Pressure wire pullback tracing
This study is pilot study evaluating the feasibility of invasive measurement and estimation of hemodynamic stress acting on plaque as well as co-registration of hemodynamic data with plaque geometric data, which is obtained by optical coherence tomography
Device
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex\> cap thickness, spotty calcification)
Device
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Interventions
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Device
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex\> cap thickness, spotty calcification)
Device
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries.
* 3\. Pressure wire pullback tracing and Optical Coherence Tomography ware successfully performed
Exclusion Criteria
* 2\. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
* 3\. Inadequate quality of Optical Coherence Tomography
* 4\. No data of Fractional Flow Reserve or Pressure wire pullback tracing or inadequate data of Fractional Flow Reserve or Pressure wire pullback tracing
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Bon-Kwon Koo
Professor of Internal Medicine and Cardiology Deparment
Principal Investigators
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Bon-Kwon Koo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Keimyung University Dongsan Medical Center
Daegu, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ulsan University Hospital, University of Ulsan College of Medicine
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCT723631
Identifier Type: -
Identifier Source: org_study_id
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