Clinical trial NCT04835467: First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Official title: First-In-Human Intracoronary Dual-modal Optical Coherence Tomography and Fluorescence Lifetime Imaging (OCT-FLIM) In Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group patient enrollment and scheduled 6-month follow-up assessment
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: day 1
Secondary outcomes:
measure: Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: day 1
measure: Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: day 1
Other outcomes:
measure: 6-month temporal changes in FLIm measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: 6 month
measure: 6-month temporal changes in FLIm measurement of healed plaque phenotype in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: 6 month
measure: 6-month temporal changes in FLIm measurement of plaque calcification in the target/culprit or non-target/non-culprit lesion (nanosecond)
timeFrame: 6 month
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Ansan Hospital
name: Sunwon Kim, MD, PhD
role: STUDY_DIRECTOR
affiliation: Korea University Guro Hospital
name: Dong Oh Kang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Korea University Guro Hospital
name: Jin Won Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Advanced Institute of Science and Technology
name: Hongki Yoo, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.