Atherosclerosis, CoronaryNCT04853511
Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability
An observational study of Atherosclerosis, Coronary and Emotional Stress, run by Korea University Guro Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Atherosclerosis, Coronary, Emotional Stress, Inflammation
- What is being tested?
- OCT-FLIM (optical coherence tomography-fluorescence life time)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Dong Oh Kang, MD, PhD, +82-2-2626-3184, gelly9@naver.com
Jin Won Kim, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis, Coronary, Emotional Stress, Inflammation, Hematopoiesis, Atherosclerosis Coronary Artery With Angina Pectoris, Atheroma; Heart
- Being tested
- OCT-FLIM (optical coherence tomography-fluorescence life time)
- Keywords
- PET-CT, Fluorescence lifetime imaging, Optical coherence tomography, High-risk plaque, Amygdalar activity, Arterial Inflammation, Hematopoietic activity, Biochemical imaging
- Medical subject headings
- Coronary Artery Disease, Stress, Psychological, Inflammation, Atherosclerosis, Acute Coronary Syndrome, Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-FLIM (optical coherence tomography-fluorescence life time)Device
Also called 18F-FDG-PET/CT (positron emission tomography-computed tomography)
comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: OCT-FLIM (optical coherence tomography-fluorescence life time) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline amygdalar activity (Stress-associated neurobiological activity)
Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV
Measured: Baseline (within index admission)
Secondary outcomes (5)
Baseline carotid inflammation (arterial atherosclerotic inflammation)
Carotid TBR = Carotid SUV / Jugular vein SUV
Measured: Baseline (within index admission)
Baseline aortic inflammation (arterial atherosclerotic inflammation)
Aorta TBR = Aorta SUV / Jugular vein SUV
Measured: Baseline (within index admission)
Baseline bone marrow hematopoiesis (hematopoietic activity)
Bone marrow TBR = Bone marrow SUV / Jugular vein SUV
Measured: Baseline (within index admission)
Baseline splenic hematopoiesis (hematopoietic activity)
Spleen TBR = Spleen SUV / Jugular vein SUV
Measured: Baseline (within index admission)
Coronary plaque composition estimated by OCT-FLIM
Fluorescence Lifetime values that predicts detailed coronary plaque composition
Measured: Baseline (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start14 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis, CoronaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Won Kim, Korea University Guro Hospital
- Investigators
- Jin Won Kim, MD, PhD, Principal investigator, Korea University Guro HospitalDong Oh Kang, MD, PhD, Study director, Korea University Guro HospitalSun Won Kim, MD, PhD, Study director, Korea UniversityHongki Yoo, PhD, Study director, Korea Advanced Institute of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853511
- Sponsor's protocol ID
- SRFC-IT1501-05_a
- Status last verified
- Aug 2022
- First submitted
- 5 Apr 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality, individual participant data (IPD) will not be shared to other researchers.
Publications
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.
PubMed 28088338Lee 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.
PubMed 30267024Kim 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.
PubMed 33341412
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853511
- Acronym / sponsor ID
- SRFC-IT1501-05_a
- Conditions
- Atherosclerosis, Coronary, Emotional Stress, Inflammation, Hematopoiesis, Atherosclerosis Coronary Artery With Angina Pectoris, Atheroma; Heart
- Keywords
- PET-CT, Fluorescence lifetime imaging, Optical coherence tomography, High-risk plaque, Amygdalar activity, Arterial Inflammation, Hematopoietic activity, Biochemical imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment | – | Device: OCT-FLIM (optical coherence tomography-fluorescence life time)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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-FLIM (optical coherence tomography-fluorescence life time)Also: 18F-FDG-PET/CT (positron emission tomography-computed tomography)comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging | Device | OCT-FLIM dual modal intravascular imaging with serial 18F-FDG-PET/CT assessment |
Primary outcome
Baseline amygdalar activity (Stress-associated neurobiological activity)
Time frame: Baseline (within index admission)
Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV
5 secondary outcomes
Baseline carotid inflammation (arterial atherosclerotic inflammation)
Time frame: Baseline (within index admission)
Baseline aortic inflammation (arterial atherosclerotic inflammation)
Time frame: Baseline (within index admission)
Baseline bone marrow hematopoiesis (hematopoietic activity)
Time frame: Baseline (within index admission)
Baseline splenic hematopoiesis (hematopoietic activity)
Time frame: Baseline (within index admission)
Coronary plaque composition estimated by OCT-FLIM
Time frame: Baseline (day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 28088338Tawakol 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.
- Background: PubMed 30267024Lee 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.
- Background: PubMed 33341412Kim 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.
- Individual participant dataSharing planned: No. Due to patient confidentiality, individual participant data (IPD) will not be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Won Kim, MD, PhD principal investigator
Korea University Guro Hospital
Dong Oh Kang, MD, PhD study director
Korea University Guro Hospital
Sun Won Kim, MD, PhD study director
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, Coronary and Emotional Stress, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Won Kim, MD, PhD (+82-2-2626-3006, kjwmm@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline amygdalar activity (Stress-associated neurobiological activity) (time frame: Baseline (within index admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853511, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.