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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04853511
Enrollment
200
Registered
2021-04-21
Start date
2022-02-14
Completion date
2024-12-31
Last updated
2022-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PET-CT, Fluorescence lifetime imaging, Optical coherence tomography, High-risk plaque, Amygdalar activity, Arterial Inflammation, Hematopoietic activity, Biochemical imaging

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.

Interventions

DEVICEOCT-FLIM (optical coherence tomography-fluorescence life time)

comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 carotid inflammation (arterial atherosclerotic inflammation)Baseline (within index admission)Carotid TBR = Carotid 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-FLIMBaseline (day 1)Fluorescence Lifetime values that predicts detailed coronary plaque composition

Other

MeasureTime frameDescription
Follow-up carotid inflammation (arterial atherosclerotic inflammation)6-month follow-upCarotid TBR = Carotid SUV / Jugular vein SUV
Follow-up aortic inflammation (arterial atherosclerotic inflammation)6-month follow-upAorta TBR = Aorta SUV / Jugular vein SUV
Follow-up bone marrow hematopoiesis (hematopoietic activity)6-month follow-upBone marrow TBR = Bone marrow SUV / Jugular vein SUV
Follow-up splenic hematopoiesis (hematopoietic activity)6-month follow-upSpleen TBR = Spleen SUV / Jugular vein SUV
Follow-up amygdalar activity (Stress-associated neurobiological activity)6-month follow-upAmygdalar TBR = Amygdalar SUV / Temporal lobe SUV

Countries

South Korea

Contacts

Primary ContactJin Won Kim, MD, PhD
kjwmm@korea.ac.kr+82-2-2626-3006
Backup ContactDong Oh Kang, MD, PhD
gelly9@naver.com+82-2-2626-3184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026