VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

Completed

• Conditions: Coronary Disease

• Registration Number: NCT01444599
• Lead Sponsor: Inje University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-10-03
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences VH-IVUS plaque composition between different FFR groups	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.	one year	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.
Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.	one year	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.

Trial Locations

Locations (4)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of