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

NCT04835467 | Completed DMC

• 1 other identifier: SRFC-IT1501-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)

  day 1

• Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)

  day 1

Other Outcomes (3)

• 6-month temporal changes in FLIm measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)

  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

• 6-month temporal changes in FLIm measurement of plaque calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)

  6 month

Study Arms (1)

Intracoronary imaging

EXPERIMENTAL

Intracoronary imaging during PCI

Device: Dual-modal OCT-FLIm

Interventions

Dual-modal OCT-FLIm DEVICE

Intracoronary imaging using dual-modal OCT-FLIm catheter

Intracoronary imaging

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (3)

• 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.

  PMID: 30267024 BACKGROUND

• 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.

  PMID: 33341412 BACKGROUND

• 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.

  PMID: 29675330 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunwon Kim, MD, PhD

  Korea University Ansan Hospital

  STUDY DIRECTOR

• Dong Oh Kang, MD, PhD

  Korea University Guro Hospital

  STUDY DIRECTOR

• Jin Won Kim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Hongki Yoo, PhD

  Korea Advanced Institute of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jin Won Kim, MD, PhD

Model Details: Single group patient enrollment and scheduled 6-month follow-up assessment

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: February 14, 2022
• Primary Completion: August 18, 2022
• Study Completion: October 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)