Centro de Pesquisa Clínica e Epidemiológica, Hospital Universitário, Universidade de São Paulo (USP), São Paulo, SP, Brazil.
Centro de Pesquisa Clínica e Epidemiológica, Hospital Universitário, Universidade de São Paulo (USP), São Paulo, SP, Brazil.
Clinics (Sao Paulo). 2022 Apr 6;77:100013. doi: 10.1016/j.clinsp.2022.100013. eCollection 2022.
This analysis describes the protocol of a study with a case-cohort to design to prospectively evaluate the incidence of subclinical atherosclerosis and Cardiovascular Disease (CVD) in Chronic Inflammatory Disease (CID) participants compared to non-diseased ones.
A high-risk group for CID was defined based on data collected in all visits on self-reported medical diagnosis, use of medicines, and levels of high-sensitivity C-Reactive Protein >10 mg/L. The comparison group is the Aleatory Cohort Sample (ACS): a group with 10% of participants selected at baseline who represent the entire cohort. In both groups, specific biomarkers for DIC, markers of subclinical atherosclerosis, and CVD morbimortality will be tested using weighted Cox.
The high-risk group (n = 2,949; aged 53.6 ± 9.2; 65.5% women) and the ACS (n=1543; 52.2±8.8; 54.1% women) were identified. Beyond being older and mostly women, participants in the high-risk group present low average income (29.1% vs. 24.8%, p < 0.0001), higher BMI (Kg/m) (28.1 vs. 26.9, p < 0.0001), higher waist circumference (cm) (93.3 vs. 91, p < 0.0001), higher frequencies of hypertension (40.2% vs. 34.5%, p < 0.0001), diabetes (20.7% vs. 17%, p = 0.003) depression (5.8% vs. 3.9%, p = 0.007) and higher levels of GlycA a new inflammatory marker (p < 0.0001) compared to the ACS.
The high-risk group selected mostly women, older, lower-income/education, higher BMI, waist circumference, and of hypertension, diabetes, depression, and higher levels of GlycA when compared to the ACS. The strategy chosen to define the high-risk group seems adequate given that multiple sociodemographic and clinical characteristics are compatible with CID.
本分析描述了一项病例队列研究的方案设计,旨在前瞻性评估慢性炎症性疾病(CID)患者与非患病者相比亚临床动脉粥样硬化和心血管疾病(CVD)的发生率。
根据在所有就诊时自我报告的医疗诊断、用药情况和高敏 C 反应蛋白水平>10mg/L,定义了 CID 的高危人群。对照组为随机队列样本(ACS):在基线时从 10%的参与者中选择一组代表整个队列的人群。在这两组人群中,将使用加权 Cox 检验检测弥散性血管内凝血(DIC)的特定生物标志物、亚临床动脉粥样硬化标志物和 CVD 发病率和死亡率。
确定了高危组(n=2949;年龄 53.6±9.2;65.5%女性)和 ACS 组(n=1543;52.2±8.8;54.1%女性)。与 ACS 组相比,高危组的参与者年龄更大,且大多数为女性,平均收入较低(29.1%比 24.8%,p<0.0001),体重指数(kg/m)较高(28.1 比 26.9,p<0.0001),腰围较大(cm)(93.3 比 91,p<0.0001),高血压的发生率较高(40.2%比 34.5%,p<0.0001),糖尿病(20.7%比 17%,p=0.003)、抑郁症(5.8%比 3.9%,p=0.007)和新的炎症标志物 GlycA 水平较高(p<0.0001)。
与 ACS 相比,高危组选择的参与者主要为女性、年龄较大、收入/教育水平较低、体重指数、腰围较大,且患有高血压、糖尿病、抑郁症,GlycA 水平较高。鉴于多种社会人口学和临床特征与 CID 相符,选择该策略来定义高危组似乎是合理的。