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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
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Daegu, Korejská republika
- Keimyung University Dongsan Medical Center
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Goyang, Korejská republika
- Inje University Ilsan Paik Hospital
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Seoul, Korejská republika
- Seoul National University Hospital
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Ulsan, Korejská republika
- Ulsan University Hospital, University of Ulsan College of Medicine
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
|
Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
Ostatní jména:
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Axial plaque stress (Axial component of total traction acting on the plaque)
Časové okno: up to 1 week
|
up to 1 week
|
|
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Cap thickness (measured from optical coherent tomography)
Časové okno: up to 1 week
|
Cap thickness measured from optical coherent tomography
|
up to 1 week
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Wall shear stress (Friction vector on the surface of the plaque)
Časové okno: up to 1 week
|
Friction vector on the surface of the plaque
|
up to 1 week
|
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Proportion of thin cap fibrous atheroma
Časové okno: up to 1 week
|
Plaques with cap thickness < 60um
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up to 1 week
|
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Cardiac death and all-cause mortality
Časové okno: 1 year
|
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
|
1 year
|
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Non-fatal target vessel myocardial infarction
Časové okno: 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
Časové okno: 1 year
|
Between High-hemodynamic force plaque and Low-hemodynamic force plaque
|
1 year
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCT723631
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