Clinical trial NCT02845505: Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
Official title: Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: intravascular ultrasonography
Computed Tomography
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-07-27
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS assessment prior to intervention will be enrolled. The patients should have at least one coronary artery lesion (including non-left main and isolated left main disease) with visually estimated diameter stenosis \>50%

Brief summary: The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.


Eligibility criteria: Inclusion Criteria:

* Age 20years or older
* Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis \>50% and take coronary angiography, CT angiography and IVUS
* Willing and able to provide informed written consent

Exclusion Criteria:

* In-stent restenosis
* Bypass graft
* Suspected coronary spasm even after sufficient nitrate injected
* Cases in which the IVUS imaging catheter failed to cross the lesion
* Poor quality IVUS or CT images
* Visible collateral flow on angiography

Primary outcomes:
measure: mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment
timeFrame: 1 year
Secondary outcomes:
measure: Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS
timeFrame: 1 year
measure: Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Pusan
country: Korea, Republic of
facility: Inje university Pusan Paik hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: