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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835467
• Other study ID #: SRFC-IT1501-05
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2023
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Atheroscleroses, Coronary
• Atherosclerosis
• Atherosclerosis Coronary Artery With Angina Pectoris
• Atherosclerotic Plaque
• Coronary Artery Disease
• Myocardial Ischemia
• Plaque, Atherosclerotic
• Thin-cap fIbroatheroma

Intervention

Device:
• Dual-modal OCT-FLIm
Intracoronary imaging using dual-modal OCT-FLIm catheter

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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