VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| low FFR group (<0.8) the patient with FFR values less than 0.8 |
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| high FFR group (>0.8) the patient with FFR values greater than 0.8 |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
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agree with informed consent
Exclusion Criteria:
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unable to get informed consent
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low left ventricular ejection fraction less than 35%
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chronic renal failure (Cr>2.0mg/dl)
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acute myocardial infarction related coronary artery
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allergy to adenosine injection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje University Ilsan Paik Hospital | Goyang | Gyeonggido | Korea, Republic of | 411-709 |
| 2 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | ||
| 3 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
| 4 | Ulsan University Hospital | Ulsan | Korea, Republic of |
Sponsors and Collaborators
- Inje University
- Seoul National University Hospital
Investigators
- Principal Investigator: Joon Hyung Doh, MDPhD, Inje University Ilsan Paik Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Kubo T, Maehara A, Mintz GS, Doi H, Tsujita K, Choi SY, Katoh O, Nasu K, Koenig A, Pieper M, Rogers JH, Wijns W, Böse 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.
- 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. Erratum in: N Engl J Med. 2011 Nov 24;365(21):2040.
- IB-1110-048