Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
- Conditions
- AtherosclerosisAcute Coronary SyndromeAtheroma; HeartAtherosclerosis, CoronaryEmotional StressHematopoiesisAtherosclerosis Coronary Artery With Angina PectorisInflammation
- Interventions
- Device: OCT-FLIM (optical coherence tomography-fluorescence life time)
- Registration Number
- NCT04853511
- Lead Sponsor
- Korea University Guro Hospital
- Brief Summary
Emotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.
- Detailed Description
Thirty two patients with multivessel coronary artery disease (including both stable angina and acute coronary syndrome), who have at least one severe obstructive lesion (\>70% diameter stenosis) that is considered suitable for percutaneous coronary intervention (PCI), will be included in the study.
Structural/biochemical characteristics of coronary culprit plaque (with or without mild to moderate stenotic non-culprit plaque) will be assessed comprehensively using OCT-FLIM dual modal intravascular imaging.
After coronary revascularization with PCI, subjects will undergo serial 18F-FDG-PET/CT molecular imaging at baseline admission and 6-month follow-up to measure PET signal activities at target tissues including amygdala, carotid artery, aorta, bone marrow, and spleen.
Correlation between OCT-FLIM parameters and baseline PET signals will be assessed to provide insight into the mechanistic linkage between multi-system metabolic activities and coronary plaque instability. Serial PET/CT imaging after 6 month will enable estimation of natural course of multi-system PET signal activities according to different levels of coronary plaque instability.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age: greater than 20, less than 75
- Patients with severe coronary atherosclerosis (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
- 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 (aspartate transaminase or alanine transferase > 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment OCT-FLIM (optical coherence tomography-fluorescence life time) Group of patients undergoing PCI with comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular imaging followed by serial 18F-FDG-PET/CT imaging
- Primary Outcome Measures
Name Time Method Baseline amygdalar activity (Stress-associated neurobiological activity) Baseline (within index admission) Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV
- Secondary Outcome Measures
Name Time Method Baseline carotid inflammation (arterial atherosclerotic inflammation) Baseline (within index admission) Carotid TBR = Carotid SUV / Jugular vein SUV
Baseline aortic inflammation (arterial atherosclerotic inflammation) Baseline (within index admission) Aorta TBR = Aorta SUV / Jugular vein SUV
Baseline bone marrow hematopoiesis (hematopoietic activity) Baseline (within index admission) Bone marrow TBR = Bone marrow SUV / Jugular vein SUV
Baseline splenic hematopoiesis (hematopoietic activity) Baseline (within index admission) Spleen TBR = Spleen SUV / Jugular vein SUV
Coronary plaque composition estimated by OCT-FLIM Baseline (day 1) Fluorescence Lifetime values that predicts detailed coronary plaque composition
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of