NCT02845505

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2016Jun 2026

First Submitted

Initial submission to the registry

July 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

August 22, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 9, 2025

Status Verified

December 1, 2023

Enrollment Period

5.7 years

First QC Date

July 13, 2016

Last Update Submit

April 6, 2025

Conditions

Coronary Artery Disease

Keywords

intravascular ultrasonographyComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment

    1 year

Secondary Outcomes (2)

  • 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

Study Arms (1)

IVUS-CAMS

patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS

Other: Intravascular Ultrasound, coronary computed tomography angiography

Interventions

Intravascular Ultrasound, coronary computed tomography angiographyOTHER
IVUS-CAMS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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%

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Location

Hallym University Sacred Heart hospital

Anyang, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Inje university Pusan Paik hospital

Pusan, South Korea

Location

Kosin University Gospel Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Veterans Hospital Medical Center

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 27, 2016

Study Start

August 22, 2016

Primary Completion

April 22, 2022

Study Completion (Estimated)

June 30, 2026

Last Updated

April 9, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(12)