Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

Study Overview
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Brief Summary
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The effect of brain-heart interaction remains unclear. The study aims to investigate the biological interconnection between brain neural activity and coronary plaque morphological and inflammatory features, as well as their connection with clinical outcomes.

Detailed Description
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Brain neural activity assessed by resting amygdalar activity (AmygA) can predict cardiovascular events. However, its biological interconnection with plaque vulnerability i is not fully understood. Coronary computed tomographic angiography (CCTA) is a non-invasive technique that enables comprehensive assessment of morphological characteristics of coronary atheroma and estimates the level of plaque instability. Recently, perivascular fat attenuation index (FAI) enables assessment of coronary inflammation by analyzing changes of perivascular adipose tissue attenuation in CCTA. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis. The present study aims to use ¹⁸F-FDG PET/CT to assess the AmygA, and to investigate its association with CCTA assessed plaque morphological and inflammatory features as well as their ability in predicting future cardiovascular disease events.

Official Title
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Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: CCTA and 18F-FDG-PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Age: greater than 20 2) Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period; 3) Patients absence of acute or chronic inﬂammatory or autoimmune disease at the time of imaging; 4) Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice 5) Patients with diameter stenosis >30% by CCTA but without coronary revascularization Exclusion Criteria: 1) Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc) 2) Coronary lesion with heavy calcification 3) Chronic renal insufficiency (Serum creatinine >2.0mg/dL) 4) Severe liver dysfunction (aspartate transaminase or alanine transferase > 5 times of upper normal limit) 5) Pregnancy or potential pregnancy 6) Life expectancy less than 5 year

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| CCTA imaging with 18F-FDG-PET/CT assessment<br>Group of patients with 18F-FDG-PET/CT imaging and Coronary Computed Tomographic Angiography within 90 days | Diagnostic Test: CCTA and 18F-FDG-PET/CT<br>* 18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity) | Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV Bone marrow TBR = Bone marrow SUV / Jugular vein SUV Correlation between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity) will be assessed | at the index imaging | 
| Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque | High-risk plaque features will be assessed by CCTA including positive remodeling (PR, defined as lesion diameter/reference diameter ≥1.1), low attenuation plaque (LAP, defined as a focal central area of plaque with an attenuation density of <30 Hounsfield Units), spotty calcification (SC, defined as focal calcification within the coronary artery wall <3mm in maximum diameter), and the napkin ring sign (defined as a central area of low attenuation plaque that had a peripheral rim of high attenuation). Correlation Between amygdalar activity and number of high-risk plaque features will be assessed. | at the index imaging | 
| Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation | Coronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed | at the index imaging | 
| Major adverse cardiac events | Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina. | 5 years after index imaging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death, or nonfatal myocardial infarction | Cardiovascular death, or nonfatal myocardial infarction | 5 years after index imaging |