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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853511
• Other study ID #: SRFC-IT1501-05_a
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Korea University Guro Hospital
• Contact: Jin Won Kim, MD, PhD
• Phone: +82-2-2626-3006
• Email: kjwmm[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Atherosclerosis
• Atherosclerosis Coronary Artery With Angina Pectoris
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Emotional Stress
• Hematopoiesis
• Inflammation
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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

Outcome

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)