AtherosclerosisNCT00114504
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
A study testing simvastatin in people with Atherosclerosis, run by Kurume University at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2004to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.
- Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes
Who cannot join
- Active inflammatory diseases
- Dyslipidemia under medications
- Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
- Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.
Read the detailed description
There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.
Originally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.
- Conditions
- Atherosclerosis
- Being tested
- simvastatin
- Keywords
- atherosclerosis, inflammation, statins, PET, carotid ultrasonography
- Medical subject headings
- Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called control
simvastatin 5-10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin group | Experimental | Patients with FDG-positive plaque who received simvastatin and diet therapy Receives: Drug: simvastatin |
| Control group | No intervention | Patients FDG-positive plaque who received diet therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Inflammation
Change in plaque inflammation was assessed by changes in the plaque SUV.
Measured: Baseline, 3 months
Secondary outcomes (1)
Circulating Inflammation Marker
Change in circulating hsCRP levels
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisashi Kai, Kurume University
- Investigators
- Hisashi Kai, MD, PhD, Principal investigator, The Third Department of Internal Medicine, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114504
- Sponsor's protocol ID
- KurumeU-2416
- Status last verified
- May 2015
- First submitted
- 15 Jun 2005
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tahara N, Kai H, Yamagishi S, Mizoguchi M, Nakaura H, Ishibashi M, Kaida H, Baba K, Hayabuchi N, Imaizumi T. Vascular inflammation evaluated by [18F]-fluorodeoxyglucose positron emission tomography is associated with the metabolic syndrome. J Am Coll Cardiol. 2007 Apr 10;49(14):1533-9. doi: 10.1016/j.jacc.2006.11.046. Epub 2007 Mar 26.
PubMed 17418291
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET
- ClinicalTrials.gov ID
- NCT00114504
- Acronym / sponsor ID
- KurumeU-2416
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, inflammation, statins, PET, carotid ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Jun 2005 (estimated)
- Results
- Posted 1 Jun 2015
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 determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.
Detailed description
There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.
Originally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin group | Experimental | Drug: simvastatinPatients with FDG-positive plaque who received simvastatin and diet therapy |
| Control group | No intervention | –Patients FDG-positive plaque who received diet therapy alone |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.
- Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes
Key exclusion criteria (4 listed)
- Active inflammatory diseases
- Dyslipidemia under medications
- Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
- Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases
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 |
|---|---|---|
| simvastatinAlso: controlsimvastatin 5-10 mg/day | Drug | Simvastatin group |
Primary outcome
Plaque Inflammation
Time frame: Baseline, 3 months
Change in plaque inflammation was assessed by changes in the plaque SUV.
1 secondary outcome
Circulating Inflammation Marker
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17418291Tahara N, Kai H, Yamagishi S, Mizoguchi M, Nakaura H, Ishibashi M, Kaida H, Baba K, Hayabuchi N, Imaizumi T. Vascular inflammation evaluated by [18F]-fluorodeoxyglucose positron emission tomography is associated with the metabolic syndrome. J Am Coll Cardiol. 2007 Apr 10;49(14):1533-9. doi: 10.1016/j.jacc.2006.11.046. Epub 2007 Mar 26.
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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.
Hisashi Kai, MD, PhD principal investigator
The Third Department of Internal Medicine, Kurume University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simvastatin in people with Atherosclerosis, run by Kurume University at 1 site in Japan.
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 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: finished, as of the sponsor's last update on 1 Jun 2015. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plaque Inflammation (time frame: Baseline, 3 months). 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 NCT00114504, 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 1 Jun 2015.