VH-IVUS Plaque Composition Analysis By Fractional Flow Reserve
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|ClinicalTrials.gov Identifier: NCT01444599|
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : March 24, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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 Start Date :||March 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
low FFR group (<0.8)
the patient with FFR values less than 0.8
high FFR group (>0.8)
the patient with FFR values greater than 0.8
- Differences VH-IVUS plaque composition between different FFR groups [ Time Frame: 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.
- Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up. [ Time Frame: 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. [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444599
|Korea, Republic of|
|Inje University Ilsan Paik Hospital|
|Goyang, Gyeonggido, Korea, Republic of, 411-709|
|Keimyung University Dongsan Medical Center|
|Daegu, Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Ulsan University Hospital|
|Ulsan, Korea, Republic of|
|Principal Investigator:||Joon Hyung Doh, MDPhD||Inje University|