Clinical trial NCT01444599: VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: coronary atherosclerosis
virtual histology intravascular ultrasound
fractional flow reserve
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2011-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent coronary angiography for the diagnostic purposes because of clinical angina pectoris. Patient who underwent simultaneous virtual histology-intravascular ultrasound (VH-IVUS)and fractional flow reserve (FFR) measurement at the time of coronary angiography would be enrolled consecutively.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences VH-IVUS plaque composition between different FFR groups
timeFrame: baseline
Secondary outcomes:
measure: Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.
timeFrame: one year
measure: Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.
timeFrame: one year
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Inje University Ilsan Paik Hospital
name: Joon Hyung Doh, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brugaletta S, Garcia-Garcia HM, Shen ZJ, Gomez-Lara J, Diletti R, Sarno G, Gonzalo N, Wijns W, de Bruyne B, Alfonso F, Serruys PW. Morphology of coronary artery lesions assessed by virtual histology intravascular ultrasound tissue characterization and fractional flow reserve. Int J Cardiovasc Imaging. 2012 Feb;28(2):221-8. doi: 10.1007/s10554-011-9816-3. Epub 2011 Feb 19.
citation: Kubo T, Maehara A, Mintz GS, Doi H, Tsujita K, Choi SY, Katoh O, Nasu K, Koenig A, Pieper M, Rogers JH, Wijns W, Bose D, Margolis MP, Moses JW, Stone GW, Leon MB. The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. J Am Coll Cardiol. 2010 Apr 13;55(15):1590-7. doi: 10.1016/j.jacc.2009.07.078.
citation: Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.