Inflammation Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Follow-up amygdalar activity (Stress-associated neurobiological activity) | Amygdalar TBR = Amygdalar SUV / Temporal lobe SUV | 6-month follow-up | |
Other | Follow-up carotid inflammation (arterial atherosclerotic inflammation) | Carotid TBR = Carotid SUV / Jugular vein SUV | 6-month follow-up | |
Other | Follow-up aortic inflammation (arterial atherosclerotic inflammation) | Aorta TBR = Aorta SUV / Jugular vein SUV | 6-month follow-up | |
Other | Follow-up bone marrow hematopoiesis (hematopoietic activity) | Bone marrow TBR = Bone marrow SUV / Jugular vein SUV | 6-month follow-up | |
Other | Follow-up splenic hematopoiesis (hematopoietic activity) | Spleen TBR = Spleen SUV / Jugular vein SUV | 6-month follow-up | |
Primary | 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 | Baseline carotid inflammation (arterial atherosclerotic inflammation) | Carotid TBR = Carotid SUV / Jugular vein SUV | Baseline (within index admission) | |
Secondary | Baseline aortic inflammation (arterial atherosclerotic inflammation) | Aorta TBR = Aorta SUV / Jugular vein SUV | Baseline (within index admission) | |
Secondary | Baseline bone marrow hematopoiesis (hematopoietic activity) | Bone marrow TBR = Bone marrow SUV / Jugular vein SUV | Baseline (within index admission) | |
Secondary | Baseline splenic hematopoiesis (hematopoietic activity) | Spleen TBR = Spleen SUV / Jugular vein SUV | Baseline (within index admission) | |
Secondary | Coronary plaque composition estimated by OCT-FLIM | Fluorescence Lifetime values that predicts detailed coronary plaque composition | Baseline (day 1) |
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