Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biological Interconnection Between Stress-associated Neurobiological Activity and Atherosclerotic Plaque Instability: A Prospective Cohort Study With OCT-FLIM Dual-modal Intravascular Imaging and Serial 18F-FDG-PET/CT Assessment

Conditions
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Atherosclerosis, Coronary, Emotional Stress, Inflammation, Hematopoiesis, Atherosclerosis Coronary Artery With Angina Pectoris, Atheroma; Heart, Atherosclerosis, Acute Coronary Syndrome

Intervention / Treatment
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* Device: OCT-FLIM (optical coherence tomography-fluorescence life time)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 (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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment<br>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 | Device: OCT-FLIM (optical coherence tomography-fluorescence life time)<br>* comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging<br>* Other names: 18F-FDG-PET/CT (positron emission tomography-computed tomography);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline amygdalar activity (Stress-associated neurobiological activity) | Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV | Baseline (within index admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline carotid inflammation (arterial atherosclerotic inflammation) | Carotid TBR = Carotid SUV / Jugular vein SUV | Baseline (within index admission) | 
| Baseline aortic inflammation (arterial atherosclerotic inflammation) | Aorta TBR = Aorta SUV / Jugular vein SUV | Baseline (within index admission) | 
| Baseline bone marrow hematopoiesis (hematopoietic activity) | Bone marrow TBR = Bone marrow SUV / Jugular vein SUV | Baseline (within index admission) | 
| Baseline splenic hematopoiesis (hematopoietic activity) | Spleen TBR = Spleen SUV / Jugular vein SUV | Baseline (within index admission) | 
| Coronary plaque composition estimated by OCT-FLIM | Fluorescence Lifetime values that predicts detailed coronary plaque composition | Baseline (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence lifetime imaging, Optical coherence tomography, High-risk plaque, Amygdalar activity, Arterial Inflammation, Hematopoietic activity, Biochemical imaging, PET-CT