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

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

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessmentOCT-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
NameTimeMethod
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
NameTimeMethod
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-FLIMBaseline (day 1)

Fluorescence Lifetime values that predicts detailed coronary plaque composition

Trial Locations

Locations (1)

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

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