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

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Other: Intravascular Ultrasound, coronary computed tomography angiography

• Registration Number: NCT02845505
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-24
• Study First Posted: 2016-07-27
• Study Start: 2016-08-22
• Primary Completion: 2022-04-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-13
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IVUS-CAMS	Intravascular Ultrasound, coronary computed tomography angiography	patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS

Primary Outcome Measures

Name	Time	Method
mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment	1 year

Secondary Outcome Measures

Name	Time	Method
Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS	1 year
Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization	1 year

Trial Locations

Locations (12)

Hallym University Sacred Heart hospital; 🇰🇷 Anyang, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Inje university Pusan Paik hospital; 🇰🇷 Pusan, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Pusan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of

Veterans Hospital Medical Center; 🇰🇷 Seoul, Korea, Republic of