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
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
复制标题
DOI：
10.1007/s40261-016-0445-4
复制
发表时间：
2016-08
影响因子：
3.2
通讯作者：
Wenbin Zhang;Yi Luan;Chong-ying Jin;Shengjie Xu;Xukun Bi;Yanbo Zhao;Fuyu Qiu;G. Fu;Min Wang
中科院分区：
文献类型：
--
作者：
Wenbin Zhang;Yi Luan;Chong-ying Jin;Shengjie Xu;Xukun Bi;Yanbo Zhao;Fuyu Qiu;G. Fu;Min Wang
前言越来越多的证据表明，钙化的密度对斑块的稳定性起着重要作用。然而，他汀类药物治疗对冠心病(CAD)和2型糖尿病患者斑块钙化密度影响的研究较少。这些患者将在未来24个月内接受瑞舒伐他汀(每天20毫克)治疗。血检和不良事件将在常规随访1、3、6、12、18和24个月时收集。主要终点是瑞舒伐他汀(20 mg/d)治疗24个月后冠状动脉CT血管造影测量的CAC密度积分与基线相比的变化。次要终点是血清硬化素的变化及其对CAC体积积分的影响。结果我们预期瑞舒伐他汀既可以增加CAC的密度以改善斑块稳定性，又可以上调血清硬化素，这可能是他汀类药物稳定斑块的潜在机制。结论本研究首次证实了瑞舒伐他汀对2型糖尿病冠心病患者冠状动脉钙化密度积分的影响。
IntroductionMore and more evidence suggests that the density of calcification plays an important role in the plaque stability. However, few studies have investigated the statin treatment on the density of plaque calcification in patients with both coronary artery disease (CAD) and type 2 diabetes mellitus.MethodsOne hundred and twenty-two CAD patients with type 2 diabetes with confirmed coronary artery calcification (CAC) will be recruited consecutively in a 12-month period. These patients will receive rosuvastatin (20 mg/day) therapy in the next 24 months. Blood tests and adverse events will be collected at routine follow-up of 1, 3, 6, 12, 18 and 24 months. The primary endpoint will be the change of CAC density score measured by coronary CT angiography after 24 months’ treatment of rosuvastatin (20 mg/day) compared with baseline. The secondary endpoints will be the change of serum sclerostin and the effect on the volume score of CAC in those patients.ResultsWe expect that rosuvastatin could both increase the density of CAC to improve plaque stability and up-regulate serum sclerostin, which would suggest the underlying mechanism of the plaque stabilization by a statin.ConclusionThis study would be the first to demonstrate the impact of rosuvastatin on the density score of coronary artery calcification in CAD patients with type 2 diabetes.This study has been registered inClinicalTrials.gov(NCT02418884).