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The present study is intended to assess the vulnerability of plaques seen on CCTA by means of TVC Imaging System and to make comparisons between plaques with adverse plaque characteristics and ones without adverse plaque characteristics in terms of plaque volume and lipid core contents.
This study is to be conducted in two phases - Phases 1 and 2. In Phase 1, the vulnerability of plaques seen on CCTA will be assessed with TVC Imaging System, and the plaque volume and lipid core contents of plaques with versus without adverse plaque characteristics will be compared. For the purpose of this study, the study of this phase will be a cross-sectional study in which the shapes of vulnerable plaques seen on CCTA will be compared to their vulnerability visualized by the TVC Imaging System.
In Phase 2, the patients with multi-vessel (polyvascular) disease of those participating in Phase 1 will be included, and the study of this phase will be a longitudinal study in which serial TVC imaging will be performed for non-target vessels, and any differences in changes of plaque vulnerability when treated with moderate-dose versus high-dose statin will be comparatively analyzed. The purpose of the present study is to determine whether there are any significant differences in changes of plaque volume and stability when treated with high-dose versus moderate-dose statin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose statin | Experimental | In high dose statin group, atorvastatin 40mg will be used |
|
| Moderate dose statin | Active Comparator | in moderate dose statin group, atorvastatin 10mg will be used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change of max LCBI(4mm): Lipid core burden index in 4 mm | The primary endpoint for this study is the change of max LCBI(4mm) between initial and follow up angiography in non-target vessel | 1 year |
| Correlation between vulnerable plaque on CT and max LCBI(4mm) | The other primary endpoint of this study is Vessel level correlation of vulnerable plaque on CT and LCBI(4mm) | maximum duration of 3 months between CT and NIRS |
| Measure | Description | Time Frame |
|---|---|---|
| the change of presence of maxLCBI(4mm) > 500 | vessel level comparison between initial and follow up angiography in non-target vessel | 1 year |
| the change of CT plaque vulnerability | the change of Positive remodeling, Low attenuation plaque, Spotty calcification |
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Inclusion Criteria:
Exclusion Criteria:
8. Contraindications of either β blockers or nitroglycerin 9. The past history of complex congenital heart disease 10. Pregnant women or women with potential childbearing 11. Body mass index (BMI) exceeding 35 12. Irregular heartbeats which disable to take CCTA 13. Contraindications of statin due to hypersensitivity, past history of serious complication such as myopathy or increased liver enzyme more than 3 times of normal upper limit
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanghoon Shin, M.D. | Contact | 82-10-8961-0707 | nephilla99@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanghoon Shin, M.D. | National Health Insurance Service Ilsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Insurance Service Ilsan Hospital | Recruiting | Goyang-si | Gyeonggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24037276 | Background | de Boer SP, Brugaletta S, Garcia-Garcia HM, Simsek C, Heo JH, Lenzen MJ, Schultz C, Regar E, Zijlstra F, Boersma E, Serruys PW. Determinants of high cardiovascular risk in relation to plaque-composition of a non-culprit coronary segment visualized by near-infrared spectroscopy in patients undergoing percutaneous coronary intervention. Eur Heart J. 2014 Feb;35(5):282-9. doi: 10.1093/eurheartj/eht378. Epub 2013 Sep 12. | |
| 23785015 |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin | Drug | in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography |
|
| 2years |
| Background |
| Yonetsu T, Suh W, Abtahian F, Kato K, Vergallo R, Kim SJ, Jia H, McNulty I, Lee H, Jang IK. Comparison of near-infrared spectroscopy and optical coherence tomography for detection of lipid. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):710-7. doi: 10.1002/ccd.25084. Epub 2013 Jul 16. |
| 23871513 | Background | Madder RD, Goldstein JA, Madden SP, Puri R, Wolski K, Hendricks M, Sum ST, Kini A, Sharma S, Rizik D, Brilakis ES, Shunk KA, Petersen J, Weisz G, Virmani R, Nicholls SJ, Maehara A, Mintz GS, Stone GW, Muller JE. Detection by near-infrared spectroscopy of large lipid core plaques at culprit sites in patients with acute ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2013 Aug;6(8):838-46. doi: 10.1016/j.jcin.2013.04.012. Epub 2013 Jul 17. |
| 24098825 | Background | Jaguszewski M, Klingenberg R, Landmesser U. Intracoronary Near-Infrared Spectroscopy (NIRS) Imaging for Detection of Lipid Content of Coronary Plaques: Current Experience and Future Perspectives. Curr Cardiovasc Imaging Rep. 2013;6(5):426-430. doi: 10.1007/s12410-013-9224-2. |
| 22019821 | Background | Pu J, Mintz GS, Brilakis ES, Banerjee S, Abdel-Karim AR, Maini B, Biro S, Lee JB, Stone GW, Weisz G, Maehara A. In vivo characterization of coronary plaques: novel findings from comparing greyscale and virtual histology intravascular ultrasound and near-infrared spectroscopy. Eur Heart J. 2012 Feb;33(3):372-83. doi: 10.1093/eurheartj/ehr387. Epub 2011 Oct 20. |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |