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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Daegu, Korea, Republik von
- Keimyung University Dongsan Medical Center
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Goyang, Korea, Republik von
- Inje University Ilsan Paik Hospital
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Seoul, Korea, Republik von
- Seoul National University Hospital
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Ulsan, Korea, Republik von
- Ulsan University Hospital, University of Ulsan College of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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)
Andere Namen:
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Axial plaque stress (Axial component of total traction acting on the plaque)
Zeitfenster: up to 1 week
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up to 1 week
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Cap thickness (measured from optical coherent tomography)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Wall shear stress (Friction vector on the surface of the plaque)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCT723631
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