Coronary Artery DiseasesNCT01665248
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
A study testing 18-F Sodium Fluoride Uptake in Positron emission tomography in people with Coronary Artery Diseases, run by CHEOL WHAN LEE, MD, PhD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Diseases
- What is being tested?
- 18-F Sodium Fluoride Uptake in Positron emission tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to May 2013
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 20
- Acute coronary syndrome or stable angina
Who cannot join
- Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media
- Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock
- Any serious medical comorbidity such that the subject's life expectancy is less than 24 months
- Ejection fraction less than 30
- Serum creatinine level of 1.5mg/dl and over
- Vasculitis
- Unwillingness or inability to cooperate or to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
- Conditions
- Coronary Artery Diseases
- Being tested
- 18-F Sodium Fluoride Uptake in Positron emission tomography
- Keywords
- 18-F Sodium Fluoride, Acute coronary syndrome, Stable Angina
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-F Sodium Fluoride Uptake in Positron emission tomographyOther
| Study group | Role | What they receive |
|---|---|---|
| stable angina pectoris or acute coronary syndrome | Other | Not described Receives: Other: 18-F Sodium Fluoride Uptake in Positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized 18F-NaF uptake value within the culprit plaque
Measured: At the time of diagnosis
Secondary outcomes (4)
The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
Measured: at the time of diagnosis
The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
Measured: at the time of diagnosis
The relationship between 18F-NaF uptake value and biomarkers
hs-CRP, Troponin-I
Measured: at the time of diagnosis
The relationship between 18F-NaF uptake value and invasive imagings
Intravascular ultrasound, Optical coherence tomography
Measured: at the time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHEOL WHAN LEE, MD, PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea
- Investigators
- Cheol Whan Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665248
- Sponsor's protocol ID
- AMCCV2012-03
- Status last verified
- Jul 2014
- First submitted
- 13 Aug 2012
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina
- ClinicalTrials.gov ID
- NCT01665248
- Acronym / sponsor ID
- AMCCV2012-03
- Conditions
- Coronary Artery Diseases
- Keywords
- 18-F Sodium Fluoride, Acute coronary syndrome, Stable Angina
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CHEOL WHAN LEE, MD, PhD.University, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Aug 2012 (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.
The purpose of this study is to evaluate the correlations between active calcification and vulnerable plaque.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stable angina pectoris or acute coronary syndrome | Other | Other: 18-F Sodium Fluoride Uptake in Positron emission tomography |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 20
- Acute coronary syndrome or stable angina
Key exclusion criteria (7 listed)
- Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal, contrast media
- Acute ST segment elevation myocardial infarction within 12hours, heart failure, cardiac shock
- Any serious medical comorbidity such that the subject's life expectancy is less than 24 months
- Ejection fraction less than 30
- Serum creatinine level of 1.5mg/dl and over
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 |
|---|---|---|
| 18-F Sodium Fluoride Uptake in Positron emission tomography | Other | stable angina pectoris or acute coronary syndrome |
Primary outcome
Standardized 18F-NaF uptake value within the culprit plaque
Time frame: At the time of diagnosis
4 secondary outcomes
The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
Time frame: at the time of diagnosis
The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
Time frame: at the time of diagnosis
The relationship between 18F-NaF uptake value and biomarkers
Time frame: at the time of diagnosis
The relationship between 18F-NaF uptake value and invasive imagings
Time frame: at the time of diagnosis
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
Related trials for Coronary Artery Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Cheol Whan Lee, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18-F Sodium Fluoride Uptake in Positron emission tomography in people with Coronary Artery Diseases, run by CHEOL WHAN LEE, MD, PhD. 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Jul 2014. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized 18F-NaF uptake value within the culprit plaque (time frame: At the time of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2014.