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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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-
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Daegu, Corée, République de
- Keimyung University Dongsan Medical Center
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Goyang, Corée, République de
- Inje University Ilsan Paik Hospital
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Seoul, Corée, République de
- Seoul National University Hospital
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Ulsan, Corée, République de
- Ulsan University Hospital, University of Ulsan College of Medicine
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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)
Autres noms:
Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Axial plaque stress (Axial component of total traction acting on the plaque)
Délai: up to 1 week
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up to 1 week
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|
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Cap thickness (measured from optical coherent tomography)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Wall shear stress (Friction vector on the surface of the plaque)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCT723631
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