Acute Coronary SyndromeNaF-PETNCT02388412
18F-NaF-PET for Identification of TCFA
An observational study of Acute Coronary Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies. In this study, the investigators will evaluate the diagnostic accuracy of 18F-NaF PET for non-invasively detecting vulnerable plaque, diagnosed by optical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Mar 2018
- How long will I take part?
- 12 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina pectoris
Who may be able to join
- 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
- 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.
Who cannot join
- 1. Stenosis at distal coronary or small vessel.
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Bon-Kwon Koo, MD, PhD, bkkoo@snu.ac.kr
Joo Myung Lee, MD, MPH, drone80@hanmail.net
About this study
Official title: Evaluating the Diagnostic Accuracy of 18F-sodium Fluoride Positron Emission Tomography for Identification of High-risk Vulnerable Coronary Atherosclerotic Plaque in Patients With Coronary Artery Disease
Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.
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).
Read the detailed description
It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Until now, evaluation of vulnerable plaque have been mainly performed with invasive imaging modalities such as optical coherence tomography or intravascular ultrasound.
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
- Acute Coronary Syndrome
- Keywords
- Positron emission tomography, Tissue background ratio, Optical coherence tomography, Thin cap fibroous atheroma, Vulnerability, Acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Measured: up to 1 week
Secondary outcomes (6)
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
Tissue-to-background ratios were calculated for each participant by dividing the maximal SUV measured in aortic valves by the mean SUV of blood in inferior vena cava
Measured: up to 1 week
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Measured: up to 1 week
Cardiac death and all-cause mortality
Between High-TBR and Low-TBR Plaque
Measured: 1 year
Non-fatal target vessel myocardial infarction
Between High-TBR and Low-TBR Plaque
Measured: 1 year
Target vessel revascularization
Between High-TBR and Low-TBR Plaque
Measured: 1 year
Target vessel restenosis
Between High-TBR and Low-TBR Plaque
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Bon-Kwon, MD, PhD, Principal investigator, Seoul National University HospitalPaeng Jin Cheol, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388412
- Sponsor's protocol ID
- NCT7895126
- Acronym
- NaF-PET
- Status last verified
- Feb 2016
- First submitted
- 4 Mar 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29133478
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Diagnostic Accuracy of 18F-sodium Fluoride Positron Emission Tomography for Identification of High-risk Vulnerable Coronary Atherosclerotic Plaque in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02388412
- Acronym / sponsor ID
- NaF-PET / NCT7895126
- Conditions
- Acute Coronary Syndrome
- Keywords
- Positron emission tomography, Tissue background ratio, Optical coherence tomography, Thin cap fibroous atheroma, Vulnerability, Acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Recently, positron emission tomography(PET) using 18F-Sodium fluoride (NaF) showed promising results for detecting vulnerable plaques in some pilot studies.
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).
Detailed description
It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Until now, evaluation of vulnerable plaque have been mainly performed with invasive imaging modalities such as optical coherence tomography or intravascular ultrasound.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina pectoris
Key inclusion criteria (4 listed)
- 1. Patients with angina pectoris who are scheduled to do invasive coronary angiography.
- 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.
Key exclusion criteria (4 listed)
- 1. Stenosis at distal coronary or small vessel.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
Time frame: up to 1 week
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque
6 secondary outcomes
Differencce of Maximum SUV value between Vulnerable and non-vulnerable plaque
Time frame: up to 1 week
Number of participants demonstrating at least 1 low-attenuation coronary atherosclerotic plaque
Time frame: up to 1 week
Cardiac death and all-cause mortality
Time frame: 1 year
Non-fatal target vessel myocardial infarction
Time frame: 1 year
Target vessel revascularization
Time frame: 1 year
Target vessel restenosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 29133478Lee 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.
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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.
Bon-Kwon Bon-Kwon, MD, PhD principal investigator
Seoul National University Hospital
Paeng Jin Cheol, MD, PhD principal investigator
Seoul National University Hospital
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 Acute Coronary Syndrome, run by Seoul National University 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 4 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 23 Feb 2016. 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 Bon-Kwon Koo, MD, PhD (82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of tissue background ratio measured by 18F-NaF PET between Vulnerable and non-vulnerable plaque (time frame: up to 1 week). 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 NCT02388412, which also lists 1 linked publication.
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 23 Feb 2016.