Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging

Atherosclerotic Plaque Clinical Trial

— OCT pathology  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649881
• Other study ID #: AMCCV2015-03
• Status: Completed
• Start date: May 12, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerotic Plaque
• Plaque, Atherosclerotic

Intervention

Procedure:
• The heart subject will undergo OCT

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Young-Hak Kim, MD, PhD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	fibrin accumulation		within 48 hours
Secondary	neoatherosclerosis		within 48 hours
Secondary	elastic lamia		within 48 hours
Secondary	cholesterol crystal		within 48 hours
Secondary	microcalcification		within 48 hours