Atheroscleroses, Coronary, Atherosclerosis, Atherosclerosis Coronary Artery With Angina Pectoris, Atherosclerotic Plaque, Thin-cap fIbroatheroma
Conditions
Keywords
Fluorescence lifetime imaging, High-risk coronary plaque, Optical coherence tomography, Intravascular imaging, Biochemical imaging
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).
Interventions
DEVICEDual-modal OCT-FLIm
Intracoronary imaging using dual-modal OCT-FLIm catheter
Sponsors
Korea University Guro Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single group patient enrollment and scheduled 6-month follow-up assessment
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescence lifetime measurement of plaque inflammation in the target/culprit or non-target/non-culprit lesion (nanosecond) | day 1 | Difference in fluorescence lifetime measurement reflecting plaque inflammation according to pre-specified plaque subtypes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescence lifetime measurement of healed plaque in the target/culprit or non-target/non-culprit lesion (nanosecond) | day 1 | Difference in fluorescence lifetime measurement reflecting healed property according to pre-specified plaque subtypes |
| Fluorescence lifetime measurement of calcification in the target/culprit or non-target/non-culprit lesion (nanosecond) | day 1 | Difference in fluorescence lifetime measurement reflecting superficial calficiation according to pre-specified plaque subtypes |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 changes in inflammatory FLIm measurement |
| 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 changes in healed phenotype FLIm measurement |
| 6-month temporal changes in FLIm measurement of plaque calcification in the target/culprit or non-target/non-culprit lesion (nanosecond) | 6 month | 6-month changes in calcification FLIm measurement |
Countries
South Korea
Outcome results
None listed