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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin group | Experimental | Patients with FDG-positive plaque who received simvastatin and diet therapy |
|
| Control group | No Intervention | Patients FDG-positive plaque who received diet therapy alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin | Drug | simvastatin 5-10 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Inflammation | Change in plaque inflammation was assessed by changes in the plaque SUV. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating Inflammation Marker | Change in circulating hsCRP levels | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisashi Kai, MD, PhD | The Third Department of Internal Medicine, Kurume University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17418291 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin Group | Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy |
| FG001 | Control Group | Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin Group | Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy |
| BG001 | Control Group | Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plaque Inflammation | Change in plaque inflammation was assessed by changes in the plaque SUV. | Posted | Mean | Standard Deviation | SUV | Baseline, 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin Group | Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hisashi Kai | Kurume University | +81-942-31-7562 | naikai@med.kurume-u.ac.jp |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Circulating Inflammation Marker | Change in circulating hsCRP levels | Posted | Mean | Standard Deviation | mg/dL | Baseline, 3 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Control Group | Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone | 0 | 22 | 0 | 22 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |