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

NCT04853511 | Unknown DMC

• 1 other identifier: SRFC-IT1501-05_a
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Baseline carotid inflammation (arterial atherosclerotic inflammation)

  Baseline (within index admission)

• Baseline aortic inflammation (arterial atherosclerotic inflammation)

  Baseline (within index admission)

• Baseline bone marrow hematopoiesis (hematopoietic activity)

  Baseline (within index admission)

• Baseline splenic hematopoiesis (hematopoietic activity)

  Baseline (within index admission)

• Coronary plaque composition estimated by OCT-FLIM

  Baseline (day 1)

Other Outcomes (5)

• Follow-up amygdalar activity (Stress-associated neurobiological activity)

  6-month follow-up

• Follow-up carotid inflammation (arterial atherosclerotic inflammation)

  6-month follow-up

• Follow-up aortic inflammation (arterial atherosclerotic inflammation)

  6-month follow-up

Study Arms (1)

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)

Interventions

OCT-FLIM (optical coherence tomography-fluorescence life time) DEVICE

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

Also known as: 18F-FDG-PET/CT (positron emission tomography-computed tomography)

OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are planned to undergo percutaneous coronary intervention with utilization of OCT-FLIM dual modal intravascular imaging for culprit plaque assessment and stent optimization. After PCI, subjects will undergo serial 18F-FDG-PET/CT molecular imaging at baseline and 6-month follow-up.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 28088338 BACKGROUND

• 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.

  PMID: 30267024 BACKGROUND

• 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. No abstract available.

  PMID: 33341412 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Stress, Psychological; Inflammation; Atherosclerosis; Acute Coronary Syndrome; Arteritis

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vasculitis

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jin Won Kim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Jin Won Kim, MD, PhD

CONTACT

+82-2-2626-3006; kjwmm@korea.ac.kr

Dong Oh Kang, MD, PhD

CONTACT

+82-2-2626-3184; gelly9@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 21, 2021
• Study Start: February 14, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)