Skip to main content
OpenTrials
Completed

NCT Number: NCT02649881

Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerotic Plaque Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The heart subject will undergo OCT

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. fibrin accumulation

    Time frame: within 48 hours

  2. neoatherosclerosis

    Time frame: within 48 hours

  3. elastic lamia

    Time frame: within 48 hours

  4. cholesterol crystal

    Time frame: within 48 hours

  5. microcalcification

    Time frame: within 48 hours

Sponsors and collaborators

Lead sponsor

Young-Hak Kim, MD, PhD

Other

Registry information

Official study title

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

Acronym: OCT pathology

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.