VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

Study Overview
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Brief Summary
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Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.

Official Title
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Virtual Histology (VH)-Intravascular Ultrasound (IVUS) Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve (FFR)

Conditions
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Coronary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography. agree with informed consent Exclusion Criteria: unable to get informed consent low left ventricular ejection fraction less than 35% chronic renal failure (Cr>2.0mg/dl) acute myocardial infarction related coronary artery allergy to adenosine injection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low FFR group (<0.8)<br>the patient with FFR values less than 0.8 | |
| high FFR group (>0.8)<br>the patient with FFR values greater than 0.8 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences VH-IVUS plaque composition between different FFR groups | VH-IVUS tissue composition (necrotic core, dense calicium, fibrotic, fibrofatty %) and atheroma type will be compared according to different FFR groups at the time of measurement procedure. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up. | Approximately 60-70 of 100 enrolled patients would be deferred according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with plaque progression and/or regression will be determined. | one year | 
| Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up. | Approximately 30-40 of 100 enrolled patients would be stented according to FFR values. Patient who provide consent for clinical and angiographic follow-up at one year would be assessed by physiologic FFR and VH-IVUS derived plaque composition including stented segment. Relationship of serial physiologic and plaque composition changes will be evaluated. Anatomic and physiologic parameters associated with stent failure will be determined. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary atherosclerosis, virtual histology intravascular ultrasound, fractional flow reserve