Development of risk prediction model for cognitive impairment in patients with coronary heart disease: A study protocol for a prospective, cross-sectional analysis

构建冠心病患者认知障碍风险预测模型:一项前瞻性横断面分析的研究方案

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Abstract

BACKGROUND: Ischemic heart disease and degenerative encephalopathy are two main sources of disease burden for the global elderly population. Coronary heart disease (CHD) and cognitive impairment, as representative diseases, are prevalent and serious illnesses in the elderly. According to recent research, patients with CHD are more likely to experience cognitive impairment and their cognitive ability declines more quickly. Vascular risk factors have been associated with differences in cognitive performance in epidemiological studies, but evidence in patients with CHD is more limited. Inextricably linked between the heart and the brain. Considering the unique characteristics of recurrent cognitive impairment in patients with CHD, we will further study the related risk factors. We tried to investigate the potential predictors of cognitive impairment in patients with CHD through a prospective, cross-sectional study. METHODS: The cross-sectional study design will recruit 378 patients with CHD (≥65 years) from Xiyuan Hospital of China Academy of Chinese Medical Sciences. The subjects' cognitive function is evaluated with MoCA scale, and they are divided into cognitive impairment group and normal cognitive function group according to the score results. Demographic data, disease characteristics (results of coronary CT/ angiography, number of stents implanted, status of diseased vessels), laboratory tests (biochemistry, coagulation, serum iron levels, pulse wave velocity), metabolites (blood samples and intestinal metabolites), and lifestyle (smoking, alcohol consumption, sleep, physical activity) will be assessed as outcome indicators. Compare the two groups and the correlation analysis will be performed on the development of mild cognitive impairment. Mann-Whitney U or X(2) test was selected to describe and evaluate the variation, and logistics regression analysis was employed to fit the prediction model. After that, do the calibration curve and decision curve to evaluate the model. The prediction model will be validated by a validation set. DISCUSSION: To explore the risk factors related to mild cognitive impairment (MCI) in patients with CHD, a new predictive model is established, which can achieve advanced intervention in the occurrence of MCI after CHD. Owing to its cross-sectional study design, the study has some limitations, but it will be further studied by increasing the observation period, adding follow-up data collection or prospective cohort study. The study has been registered with the China Clinical Trials Registry (ChiCTR2200063255) to conduct clinical trials.

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