VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve

NCT ID: NCT01444599

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Coronary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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low FFR group (<0.8)

the patient with FFR values less than 0.8

No interventions assigned to this group

high FFR group (>0.8)

the patient with FFR values greater than 0.8

No interventions assigned to this group

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role lead

Responsible Party

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Joon Hyung Doh

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon Hyung Doh, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital

Locations

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Inje University Ilsan Paik Hospital

Goyang, Gyeonggido, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 21336551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20378076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21247313 (View on PubMed)

Other Identifiers

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IB-1110-048

Identifier Type: -

Identifier Source: org_study_id

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