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First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

Primary Purpose

Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dual-modal OCT-FLIm
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atherosclerosis Coronary Artery With Angina Pectoris focused on measuring Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: greater than 20, less than 75
  • Patients with significant coronary artery disease (diameter stenosis >70%) requiring coronary revascularization
  • Reference vessel diameter: between 2.5 and 4.0 mm
  • Obtained informed consent from voluntary participants before study enrollment

Exclusion Criteria:

  • Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
  • Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
  • Coronary lesion with heavy calcification
  • Hemodynamic instability during coronary intervention
  • Contraindication to antithrombotic therapy
  • Chronic renal insufficiency (Serum creatinine >2.0mg/dL)
  • Severe liver dysfunction (AST/ALT > 5 times of upper normal limit)
  • Pregnancy or potential pregnancy
  • Life expectancy less than 1 year
  • Patient refused to sign the informed consent at enrollment

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intracoronary imaging

Arm Description

Intracoronary imaging during PCI

Outcomes

Primary Outcome Measures

Ability of OCT-FLIm in assessing high-risk plaques
Lifetime difference according to plaque types

Secondary Outcome Measures

Ability of OCT-FLIm in assessing plaque compositions
Lifetime difference according to plaque compositions

Full Information

First Posted
April 5, 2021
Last Updated
August 22, 2022
Sponsor
Korea University Guro Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04835467
Brief Title
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Official Title
First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.
Detailed Description
Fluorescence lifetime imaging (FLIm) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. A combined optical coherence tomography (OCT) and FLIm that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. This study sought to investigate whether the dual-modal intravascular OCT-FLIm is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention. Thirty two patients with multivessel coronary artery disease, who had at least one obstructive lesion (>70% diameter stenosis) that is considered suitable for PCI, will be included in the study. Culprit and mildly stenotic non-culprit plaques will be imaged using OCT-FLIm catheter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque, Thin-cap fIbroatheroma, Atherosclerosis
Keywords
Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracoronary imaging
Arm Type
Experimental
Arm Description
Intracoronary imaging during PCI
Intervention Type
Device
Intervention Name(s)
Dual-modal OCT-FLIm
Intervention Description
Intracoronary imaging using dual-modal OCT-FLIm catheter
Primary Outcome Measure Information:
Title
Ability of OCT-FLIm in assessing high-risk plaques
Description
Lifetime difference according to plaque types
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Ability of OCT-FLIm in assessing plaque compositions
Description
Lifetime difference according to plaque compositions
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: greater than 20, less than 75 Patients with significant coronary artery disease (diameter stenosis >70%) requiring coronary revascularization Reference vessel diameter: between 2.5 and 4.0 mm Obtained informed consent from voluntary participants before study enrollment Exclusion Criteria: Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc) Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm Coronary lesion with heavy calcification Hemodynamic instability during coronary intervention Contraindication to antithrombotic therapy Chronic renal insufficiency (Serum creatinine >2.0mg/dL) Severe liver dysfunction (AST/ALT > 5 times of upper normal limit) Pregnancy or potential pregnancy Life expectancy less than 1 year Patient refused to sign the informed consent at enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunwon Kim, MD, PhD
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dong Oh Kang, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jin Won Kim, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongki Yoo, PhD
Organizational Affiliation
Korea Advanced Institute of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30267024
Citation
Lee MW, Song JW, Kang WJ, Nam HS, Kim TS, Kim S, Oh WY, Kim JW, Yoo H. Comprehensive intravascular imaging of atherosclerotic plaque in vivo using optical coherence tomography and fluorescence lifetime imaging. Sci Rep. 2018 Sep 28;8(1):14561. doi: 10.1038/s41598-018-32951-9.
Results Reference
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PubMed Identifier
33341412
Citation
Kim S, Yoo H, Kim JW. Long Journey of Intravascular Imaging: What and How to Look at the Atheroma in Coronary Artery. JACC Cardiovasc Imaging. 2021 Sep;14(9):1843-1845. doi: 10.1016/j.jcmg.2020.11.015. Epub 2020 Dec 16. No abstract available.
Results Reference
background
PubMed Identifier
29675330
Citation
Nam HS, Kang WJ, Lee MW, Song JW, Kim JW, Oh WY, Yoo H. Multispectral analog-mean-delay fluorescence lifetime imaging combined with optical coherence tomography. Biomed Opt Express. 2018 Mar 27;9(4):1930-1947. doi: 10.1364/BOE.9.001930. eCollection 2018 Apr 1.
Results Reference
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First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

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