Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging

Completed

• Conditions: Atherosclerotic Plaque
• Interventions: Procedure: The heart subject will undergo OCT

• Registration Number: NCT02649881
• Lead Sponsor: Young-Hak Kim, MD, PhD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
isolated heart from heart transplantation	The heart subject will undergo OCT	-

Primary Outcome Measures

Name	Time	Method
ROC curve of diagnosis	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 Outcome Measures

Name	Time	Method
cholesterol crystal	within 48 hours
microcalcification	within 48 hours
neoatherosclerosis	within 48 hours
fibrin accumulation	within 48 hours
elastic lamia	within 48 hours

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of