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NCT02845505 Clinical Trial

Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion

Coronary Artery Disease Clinical Trial

— IVUS-CAMS  

Official title:
Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02845505
Other study ID # AMCCV 2016-06
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 22, 2016
Est. completion date June 30, 2024

Study information
Verified date December 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date June 30, 2024
Est. primary completion date April 22, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Intravascular Ultrasound, coronary computed tomography angiography

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart hospital Anyang
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Gangneung Asan Hospital Gangneung
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Gyeonggi-do
Korea, Republic of Inje university Pusan Paik hospital Pusan
Korea, Republic of Kosin University Gospel Hospital Pusan
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Asan Medical Center Seoul Songpa-Gu
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Veterans Hospital Medical Center Seoul
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (2)
Lead Sponsor Collaborator
Asan Medical Center Boston Scientific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment 1 year
Secondary Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS 1 year
Secondary Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization 1 year
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