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

First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Atheroscleroses, Coronary; Atherosclerotic Plaque; Atherosclerosis Coronary Artery With Angina Pectoris; Thin-cap fIbroatheroma
• Intervention / Treatment: Device: Dual-modal OCT-FLIm

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.

Forty 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.

Six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in FLIm signatures according to treatment strategies (medical therapy, interventional therapy etc).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: greater than 20, less than 80
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracoronary imaging; Intracoronary imaging during PCI	Device: Dual-modal OCT-FLIm; Intracoronary imaging using dual-modal OCT-FLIm catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)	Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)	Difference in fluorescence lifetime measurement reflecting healed property according to pre-specified plaque subtypes	day 1
Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)	Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes	day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month temporal changes in FLIm measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)	6-month changes in inflammatory FLIm measurement	6 month
6-month temporal changes in FLIm measurement of healed plaque phenotype in the target/culprit or non-target/non-culprit lesion (nanosecond)	6-month changes in healed phenotype FLIm measurement	6 month
6-month temporal changes in FLIm measurement of plaque calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)	6-month changes in calcification FLIm measurement	6 month

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Jin Won Kim, MD, PhD, Korea University Guro Hospital; Study Director: Dong Oh Kang, MD, PhD, Korea University Guro Hospital; Study Director: Hongki Yoo, PhD, Korea Advanced Institute of Science and Technology; Study Director: Sunwon Kim, MD, PhD, Korea University Ansan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Fluorescence lifetime imaging; Biochemical imaging; Intravascular imaging; High-risk coronary plaque
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Coronary Disease; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Angina Pectoris; Plaque, Atherosclerotic
• Other Study ID Numbers: SRFC-IT1501-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No