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临床试验/NCT05134129
NCT05134129招募中不适用

Correlation Between Targeted Hemoglobin A1C Levels and Prevention of Recurrent Cardiovascular Events in Type 2 Diabetes After Coronary Intervention

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Coronary revascularization

研究概览

简要总结

Diabetes is a leading social and economic burden in the world. It is the main reason of macrovascular disease incidence and mortality. Prospective studies have demonstrated that high glycosylated hemoglobin (HbA1C) levels are associated with an increased risk of cardiovascular events in a population of diabetic patients without a history of coronary artery disease. Further, the predictive value of high preprocedural glycemia levels has been reported in diabetic patients undergoing percutaneous coronary intervention (PCI). The aim of the present study was to assess the predictive value of preprocedural HbA1C levels for cardiovascular complications in a large population of diabetic patients undergoing PCI with stent implantation. Glycosylated hemoglobin (HbA1c) reflects the average blood sugar level in the past 2-3 months. As glycosylated hemoglobin has been clinically tested and standardized internationally, increasing evidence is recommended for routine monitoring in diabetes care. The American Diabetes Association (ADA) suggested that in the treatment of diabetes, blood sugar control should control HbA1c level below 6.5%. Although,there is evidence that controlling blood glucose can reduce the incidence of microvascular complications, in the past three trials, intensive glycemic control did not significantly reduce adverse CV events in patients with onger duration of diabetes.Therefore, most primary and secondary prevention guidelines recommend HbA1c below 6.5% or 7% to prevent adverse cardiovascular outcomes in patients with diabetes mellitus. The optimal target level of glycosylated hemoglobin is still hotly debated. In addition, there is still lack of evidence for the level of HbA1c in patients with major vascular disease history in secondary prevention of recurrence cardiovascular events.

Therefore, to explore and determine the optimal level of blood glucose control is the focus of controversy in preventing recurrence cardiovascular events in diabetic patients. Investigator will combine epidemiology and metabolomics to study the effect of glycosylated hemoglobin on secondary cardiovascular events, and further determine whether to strengthen hypoglycemic treatment after PCI.

详细描述

This is a longitudinal cohort study including retrospective study, prospective study and nested case-control study.The first cross-sectional survey was conducted in 2021.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18, male or female;
  • all patients with diabetes combined with PCI operation;

排除标准

  • Less than 18 years old
  • Patients with preoperative glycosylated hemoglobin index deficiency
  • Chronic maintenance hemodialysis patients

结局指标

主要结局

Coronary revascularization

时间窗: 3 years

Coronary revascularization includes percutaneous coronary intervention, or/and percutaneous coronary artery dilatation, or/and percutaneous coronary artery bypass grafting.

All cause mortality

时间窗: 3 years

which refers to the total death caused by various causes in a certain period.

Differential polar compound

时间窗: 3 years

Metabonomic analysis uses non targeted detection methods to detect polar compounds in blood. The characteristic peaks of detectable substances were detected by chromatographic Series platform, and then these characteristic peaks were compared with the standard library containing more than 8000 metabolites, annotated the compounds, and screened out the different metabolites between groups.

Cardiac mortality

时间窗: 3 years

Cardiac death refers to the death caused by serious cardiac dysfunction or failure caused by heart disease or injury in a certain period.

Differential lipid compounds

时间窗: 3 years

Metabonomic analysis uses non targeted detection methods to detect lipid compounds in blood. The characteristic peaks of detectable substances were detected by chromatographic Series platform, and then these characteristic peaks were compared with the standard library containing more than 8000 metabolites, annotated the compounds, and screened out the different metabolites between groups.

次要结局

未报告次要终点

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

Chief Physician

Shanghai 10th People's Hospital

研究点 (1)

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