VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444599

Enrollment

100

Registered

2011-10-03

Start date

2010-03-31

Completion date

2014-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

coronary atherosclerosis, virtual histology intravascular ultrasound, fractional flow reserve

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results