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

December 11, 2023 updated by: Young-Hak Kim, MD, PhD, Asan Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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%

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVUS-CAMS
patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS
Other: Intravascular Ultrasound, coronary computed tomography angiography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2016

Primary Completion (Actual)

April 22, 2022

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 24, 2016

First Posted (Estimated)

July 27, 2016

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV 2016-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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