Invasive Measurement of Axial Plaque Stress, the Pilot Study (REASSURE)
Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data
In this study, the investigators 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, the investigators will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Although current risk assessment for plaque rupture have mainly focused on evaluation of plaque vulnerability. However, according to the general mechanism of material failure, plaque rupture occurs whenever the external hemodynamic stress exceeds the durability of the plaque.
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joo Myung Lee, MD, MPH
- Número de teléfono: 82-2-2072-2062
- Correo electrónico: drone80@hanmail.net
Ubicaciones de estudio
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Daegu, Corea, república de
- Keimyung University Dongsan Medical Center
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Investigador principal:
- Chang-Wook Nam, MD, PhD
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Contacto:
- Chang-Wook Nam, MD, PhD
- Correo electrónico: ncwcv@dsmc.or.kr
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Goyang, Corea, república de
- Inje University Ilsan Paik Hospital
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Investigador principal:
- Joon-Hyung Doh, MD, PhD
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Contacto:
- Joon-Hyung Doh, MD, PhD
- Correo electrónico: joon.doh@gmail.com
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Seoul, Corea, república de
- Seoul National University Hospital
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Contacto:
- Bon-Kwon Koo, MD, PhD
- Correo electrónico: bkkoo@snu.ac.kr
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Contacto:
- Joo Myung Lee, MD, MPH
- Correo electrónico: drone80@hanmail.net
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Sub-Investigador:
- Joo Myung Lee, MD, MPH
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Ulsan, Corea, república de
- Ulsan University Hospital, University of Ulsan College of Medicine
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Contacto:
- Eun-Seok Shin, MD, PhD
- Correo electrónico: ses@uuh.ulsan.kr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
- 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:
- 1. Stenosis at distal coronary or small vessel.
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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
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Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
Otros nombres:
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Axial plaque stress (Axial component of total traction acting on the plaque)
Periodo de tiempo: up to 1 week
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up to 1 week
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Cap thickness (measured from optical coherent tomography)
Periodo de tiempo: up to 1 week
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Cap thickness measured from optical coherent tomography
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up to 1 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Wall shear stress (Friction vector on the surface of the plaque)
Periodo de tiempo: up to 1 week
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Friction vector on the surface of the plaque
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up to 1 week
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Proportion of thin cap fibrous atheroma
Periodo de tiempo: up to 1 week
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Plaques with cap thickness < 60um
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up to 1 week
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Cardiac death and all-cause mortality
Periodo de tiempo: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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Non-fatal target vessel myocardial infarction
Periodo de tiempo: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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Target vessel restenosis
Periodo de tiempo: 1 year
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Between High-hemodynamic force plaque and Low-hemodynamic force plaque
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1 year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCT723631
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