Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
NCT ID: NCT04853511
Last Updated: 2022-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-02-14
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Responsible Party
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Jin Won Kim
Principal Investigator
Principal Investigators
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Jin Won Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Dong Oh Kang, MD, PhD
Role: STUDY_DIRECTOR
Korea University Guro Hospital
Sun Won Kim, MD, PhD
Role: STUDY_DIRECTOR
Korea University
Hongki Yoo, PhD
Role: STUDY_DIRECTOR
Korea Advanced Institute of Science and Technology
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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SRFC-IT1501-05_a
Identifier Type: -
Identifier Source: org_study_id
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