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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
96 participants
OBSERVATIONAL
2015-03-31
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
18F-fluoride (18F-NaF) PET for Identifying Coronary Atherosclerotic Plaques
NCT02607748
Prediction of Recurrent Events With 18F-Fluoride
NCT02278211
Evaluation of FFR, WSS, and TPF Using CCTA
NCT01857687
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
NCT01665248
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
NCT03095313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.
In this study, we will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical coherence tomography (OCT).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vulnerable plaque in optical coherence tomogrpahy
OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels.
No interventions assigned to this group
Non-vulnerable plaque in Optical coherence tomogrpahy
OCT-derived vulnerable plaque is defined as composite of thin-cap fibrous atheroma (cap thickness in optical coherence tomography \< 60um), prominent macrophage, or prominent microvessels. OCT-derived non-vulnerable plaque is defined as a plaque without any of the findings
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2\. Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by coronary CT angiography.
* 3\. Patients who are anticipated coronary artery disease.(Probability \> 90 %)
* 4\. Acute coronary syndrome.
Exclusion Criteria
* 2\. Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
* 3\. Inadequate quality of 18F-NaF PET-CT
* 4\. Inadequate quality of Optical Coherence Tomography (OCT), IVUS, Coronary CT angiography
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bon-Kwon Koo
Professor of Internal Medicine and Cardiology Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bon-Kwon Bon-Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Paeng Jin Cheol, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Lee JM, Bang JI, Koo BK, Hwang D, Park J, Zhang J, Yaliang T, Suh M, Paeng JC, Shiono Y, Kubo T, Akasaka T. Clinical Relevance of 18F-Sodium Fluoride Positron-Emission Tomography in Noninvasive Identification of High-Risk Plaque in Patients With Coronary Artery Disease. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006704. doi: 10.1161/CIRCIMAGING.117.006704.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCT7895126
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.