An observational study in Coronary Disease, sponsored by Inje University. Completed at 4 sites in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Inje University · Observational
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.
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's enrollment of 100 is below the median of 460 across 953 observational studies indexed under Coronary Disease.
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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.
Exclusion Criteria:
the patient with FFR values less than 0.8
the patient with FFR values greater than 0.8
Differences VH-IVUS plaque composition between different FFR groups
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.
Time frame: baseline
Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.
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.
Time frame: one year
Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.
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.
Time frame: one year
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Inje University