NCT02649881

Brief Summary

This study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 12, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2.3 years

First QC Date

January 6, 2016

Last Update Submit

September 5, 2018

Conditions

Atherosclerotic Plaque

Keywords

macrophagevulnerable coronary plaque

Outcome Measures

Primary Outcomes (1)

  • ROC curve of diagnosis

    Receiver Operating Characteristic curve of diagnosis through existing NSD(normalized standard deviation)-based method and developed algorithm in the diagnosis of coronary plaque accompanied with macrophage infiltration

    within 48 hours

Secondary Outcomes (5)

  • fibrin accumulation

    within 48 hours

  • neoatherosclerosis

    within 48 hours

  • elastic lamia

    within 48 hours

  • cholesterol crystal

    within 48 hours

  • microcalcification

    within 48 hours

Study Arms (1)

isolated heart from heart transplantation

Procedure: The heart subject will undergo OCT

Interventions

The heart subject will undergo OCTPROCEDURE
isolated heart from heart transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is targeted at the isolated heart voluntarily donated from adult patients who receive heart transplantation

You may qualify if:

  • Age 18 and above
  • Patients who are to receive heart transplantation
  • Patients or their legal representatives who gave a prior written consent

You may not qualify if:

  • Impossible to OCT and IVUS analysis due to severe coronary stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division of Cardiology

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

May 12, 2015

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

This is not publicly funded trial.

Locations

KR(1)