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

NCT ID: NCT04835467

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2023-10-31

Brief Summary

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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

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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).

Conditions

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Atherosclerosis Coronary Artery With Angina Pectoris Atheroscleroses, Coronary Atherosclerotic Plaque Thin-cap fIbroatheroma Atherosclerosis

Keywords

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Fluorescence lifetime imaging High-risk coronary plaque Optical coherence tomography Intravascular imaging Biochemical imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group patient enrollment and scheduled 6-month follow-up assessment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intracoronary imaging

Intracoronary imaging during PCI

Group Type EXPERIMENTAL

Dual-modal OCT-FLIm

Intervention Type DEVICE

Intracoronary imaging using dual-modal OCT-FLIm catheter

Interventions

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Dual-modal OCT-FLIm

Intracoronary imaging using dual-modal OCT-FLIm catheter

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin Won Kim

Jin Won Kim, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunwon Kim, MD, PhD

Role: STUDY_DIRECTOR

Korea University Ansan Hospital

Dong Oh Kang, MD, PhD

Role: STUDY_DIRECTOR

Korea University Guro Hospital

Jin Won Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Hongki Yoo, PhD

Role: STUDY_DIRECTOR

Korea Advanced Institute of Science and Technology

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 30267024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33341412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29675330 (View on PubMed)

Other Identifiers

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SRFC-IT1501-05

Identifier Type: -

Identifier Source: org_study_id