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

• Sponsor: Korea University Guro Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04835467
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Coronary Artery With Angina Pectoris; Atheroscleroses, Coronary; Atherosclerotic Plaque; Thin-cap fIbroatheroma; Atherosclerosis	Device: Dual-modal OCT-FLIm	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
• Actual Study Start Date: Feb 14, 2022
• Actual Primary Completion Date: Aug 18, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ability of OCT-FLIm in assessing high-risk plaques [day 1]

   Lifetime difference according to plaque types

Secondary Outcome Measures

1. Ability of OCT-FLIm in assessing plaque compositions [day 1]

   Lifetime difference according to plaque compositions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

• Korea University Guro Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Jin Won Kim, Jin Won Kim, MD, PhD, Korea University Guro Hospital
• ClinicalTrials.gov Identifier: NCT04835467
• Other Study ID Numbers: SRFC-IT1501-05
• First Posted: Apr 8, 2021
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jin Won Kim, Jin Won Kim, MD, PhD, Korea University Guro Hospital: Fluorescence lifetime imaging; High-risk coronary plaque; Optical coherence tomography; Intravascular imaging; Biochemical imaging
• Additional relevant MeSH terms: Atherosclerosis; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Plaque, Atherosclerotic

Study Results

No Results Posted as of Aug 24, 2022