Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment 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)
comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- Follow-up amygdalar activity (Stress-associated neurobiological activity) [6-month follow-up]
Amygdalar TBR = Amygdalar SUV / Temporal lobe SUV
- Follow-up carotid inflammation (arterial atherosclerotic inflammation) [6-month follow-up]
Carotid TBR = Carotid SUV / Jugular vein SUV
- Follow-up aortic inflammation (arterial atherosclerotic inflammation) [6-month follow-up]
Aorta TBR = Aorta SUV / Jugular vein SUV
- Follow-up bone marrow hematopoiesis (hematopoietic activity) [6-month follow-up]
Bone marrow TBR = Bone marrow SUV / Jugular vein SUV
- Follow-up splenic hematopoiesis (hematopoietic activity) [6-month follow-up]
Spleen TBR = Spleen SUV / Jugular vein SUV
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 |
Sponsors and Collaborators
- Korea University Guro Hospital
Investigators
- Principal Investigator: Jin Won Kim, MD, PhD, Korea University Guro Hospital
- Study Director: Dong Oh Kang, MD, PhD, Korea University Guro Hospital
- Study Director: Sun Won Kim, MD, PhD, Korea University
- Study Director: Hongki Yoo, PhD, Korea Advanced Institute of Science and Technology
Study Documents (Full-Text)
None provided.More Information
Publications
- Kim S, Yoo H, Kim JW. Long Journey of Intravascular Imaging: What and How to Look at the Atheroma in Coronary Artery. JACC Cardiovasc Imaging. 2021 Sep;14(9):1843-1845. doi: 10.1016/j.jcmg.2020.11.015. Epub 2020 Dec 16.
- Lee MW, Song JW, Kang WJ, Nam HS, Kim TS, Kim S, Oh WY, Kim JW, Yoo H. Comprehensive intravascular imaging of atherosclerotic plaque in vivo using optical coherence tomography and fluorescence lifetime imaging. Sci Rep. 2018 Sep 28;8(1):14561. doi: 10.1038/s41598-018-32951-9.
- Tawakol A, Ishai A, Takx RA, Figueroa AL, Ali A, Kaiser Y, Truong QA, Solomon CJ, Calcagno C, Mani V, Tang CY, Mulder WJ, Murrough JW, Hoffmann U, Nahrendorf M, Shin LM, Fayad ZA, Pitman RK. Relation between resting amygdalar activity and cardiovascular events: a longitudinal and cohort study. Lancet. 2017 Feb 25;389(10071):834-845. doi: 10.1016/S0140-6736(16)31714-7. Epub 2017 Jan 12. Erratum in: Lancet. 2017 Feb 25;389(10071):804. Erratum in: Lancet. 2017 Feb 25;389(10071):804.
- SRFC-IT1501-05_a