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This study is designed to validate the hypothesis that the treatment of rosuvastatin could increase the score of Calcification of Coronary artery(CAC) density in coronary artery disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Calcification of atherosclerotic plaque is a complicated and organic active process, which is one of the main pathologic features of atherosclerosis. Widely coverage of CAC is correlated with the greater likelihood of coronary events.With the increasing density of CAC, the risk of cardiovascular disease (CVD) declines.Some studies showed that the calcified plaque in stable CHD is denser.
Statins are widely used in the treatment of atherosclerotic cardiovascular disease. Treatment of statins may increase the density score of CAC, thus, promote the unstable atherosclerotic plaque to the stable plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD+DM | Other | Using self controlled study to validate the hypothesis that the treatment of rosuvastatin could increase the score of CAC density in CAD patients with diabetes mellitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosuvastatin | Drug | CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| the level of serum sclerostin in CAD patients with diabetes mellitus | 24months | |
| the volume score of CAC in CAD patients with diabetes mellitus | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guosheng Fu, MD/PhD | Contact | maoyihui_007@163.com | ||
| Wenbin Zhang | Contact | dream_flash_mx@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guosheng Fu, MD/PhD | Sir Run Run Shaw Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10673250 | Background | Schoenhagen P, Ziada KM, Kapadia SR, Crowe TD, Nissen SE, Tuzcu EM. Extent and direction of arterial remodeling in stable versus unstable coronary syndromes : an intravascular ultrasound study. Circulation. 2000 Feb 15;101(6):598-603. doi: 10.1161/01.cir.101.6.598. | |
| 12633805 | Background | Leber AW, Knez A, White CW, Becker A, von Ziegler F, Muehling O, Becker C, Reiser M, Steinbeck G, Boekstegers P. Composition of coronary atherosclerotic plaques in patients with acute myocardial infarction and stable angina pectoris determined by contrast-enhanced multislice computed tomography. Am J Cardiol. 2003 Mar 15;91(6):714-8. doi: 10.1016/s0002-9149(02)03411-2. No abstract available. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 12563143 | Background | Shemesh J, Apter S, Itzchak Y, Motro M. Coronary calcification compared in patients with acute versus in those with chronic coronary events by using dual-sector spiral CT. Radiology. 2003 Feb;226(2):483-8. doi: 10.1148/radiol.2262011903. |
| 15557374 | Background | Ehara S, Kobayashi Y, Yoshiyama M, Shimada K, Shimada Y, Fukuda D, Nakamura Y, Yamashita H, Yamagishi H, Takeuchi K, Naruko T, Haze K, Becker AE, Yoshikawa J, Ueda M. Spotty calcification typifies the culprit plaque in patients with acute myocardial infarction: an intravascular ultrasound study. Circulation. 2004 Nov 30;110(22):3424-9. doi: 10.1161/01.CIR.0000148131.41425.E9. Epub 2004 Nov 22. |
| 16449511 | Background | Houslay ES, Cowell SJ, Prescott RJ, Reid J, Burton J, Northridge DB, Boon NA, Newby DE; Scottish Aortic Stenosis and Lipid Lowering Therapy, Impact on Regression trial Investigators. Progressive coronary calcification despite intensive lipid-lowering treatment: a randomised controlled trial. Heart. 2006 Sep;92(9):1207-12. doi: 10.1136/hrt.2005.080929. Epub 2006 Jan 31. |
| 17560880 | Background | Terry JG, Carr JJ, Kouba EO, Davis DH, Menon L, Bender K, Chandler ET, Morgan T, Crouse JR 3rd. Effect of simvastatin (80 mg) on coronary and abdominal aortic arterial calcium (from the coronary artery calcification treatment with zocor [CATZ] study). Am J Cardiol. 2007 Jun 15;99(12):1714-7. doi: 10.1016/j.amjcard.2007.01.060. Epub 2007 Apr 26. |
| 24247483 | Background | Criqui MH, Denenberg JO, Ix JH, McClelland RL, Wassel CL, Rifkin DE, Carr JJ, Budoff MJ, Allison MA. Calcium density of coronary artery plaque and risk of incident cardiovascular events. JAMA. 2014 Jan 15;311(3):271-8. doi: 10.1001/jama.2013.282535. |
| 24151757 | Background | Koos R, Brandenburg V, Mahnken AH, Schneider R, Dohmen G, Autschbach R, Marx N, Kramann R. Sclerostin as a potential novel biomarker for aortic valve calcification: an in-vivo and ex-vivo study. J Heart Valve Dis. 2013 May;22(3):317-25. |
| 24112318 | Background | Brandenburg VM, Kramann R, Koos R, Kruger T, Schurgers L, Muhlenbruch G, Hubner S, Gladziwa U, Drechsler C, Ketteler M. Relationship between sclerostin and cardiovascular calcification in hemodialysis patients: a cross-sectional study. BMC Nephrol. 2013 Oct 10;14:219. doi: 10.1186/1471-2369-14-219. |
| 27541380 | Derived | Zhang W, Luan Y, Jin C, Xu S, Bi X, Zhao Y, Qiu F, Fu G, Wang M. The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in Coronary Artery Disease Patients with Type 2 Diabetes Mellitus: Rationale and Design of RosCal Study. Clin Drug Investig. 2016 Dec;36(12):1023-1029. doi: 10.1007/s40261-016-0445-4. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |