Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging (OCT pathology)

September 5, 2018 updated by: Young-Hak Kim, MD, PhD

Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging : A Comparative Study With Coronary Artery of the Transplanted or Autopsy Heart

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
isolated heart from heart transplantation
Procedure: The heart subject will undergo OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROC curve of diagnosis
Time Frame: within 48 hours
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 Outcome Measures

Outcome Measure
Time Frame
fibrin accumulation
Time Frame: within 48 hours
within 48 hours
neoatherosclerosis
Time Frame: within 48 hours
within 48 hours
elastic lamia
Time Frame: within 48 hours
within 48 hours
cholesterol crystal
Time Frame: within 48 hours
within 48 hours
microcalcification
Time Frame: within 48 hours
within 48 hours

Collaborators and Investigators

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

Sponsor

Young-Hak Kim, MD, PhD

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)

May 12, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2015-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not publicly funded trial.

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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