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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracoronary imaging | Experimental | Intracoronary imaging during PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-modal OCT-FLIm | Device | Intracoronary imaging using dual-modal OCT-FLIm catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 6-month temporal changes in FLIm measurement of healed plaque phenotype in the target/culprit or non-target/non-culprit lesion (nanosecond) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30267024 | Background | 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. | |
| 33341412 | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single group patient enrollment and scheduled 6-month follow-up assessment
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Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes |
| day 1 |
6-month changes in healed phenotype FLIm measurement |
| 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 changes in calcification FLIm measurement | 6 month |
| 29675330 | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |