OCT pathology: Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging

• Sponsor: Young-Hak Kim, MD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02649881
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 27.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerotic Plaque	Procedure: The heart subject will undergo OCT

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging : A Comparative Study With Coronary Artery of the Transplanted or Autopsy Heart
• Actual Study Start Date: May 12, 2015
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. fibrin accumulation [within 48 hours]

2. neoatherosclerosis [within 48 hours]

3. elastic lamia [within 48 hours]

4. cholesterol crystal [within 48 hours]

5. microcalcification [within 48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-Gu	Korea, Republic of

Sponsors and Collaborators

• Young-Hak Kim, MD, PhD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Hak Kim, MD, PhD, Division of Cardiology, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02649881
• Other Study ID Numbers: AMCCV2015-03
• First Posted: Jan 8, 2016
• Last Update Posted: Sep 6, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Young-Hak Kim, MD, PhD, Division of Cardiology, Asan Medical Center: macrophage; vulnerable coronary plaque
• Additional relevant MeSH terms: Plaque, Atherosclerotic

Study Results

No Results Posted as of Sep 6, 2018