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临床试验/NCT04529590
NCT04529590已完成不适用

Precise Treatment of Prediabetes and Stage 1 Hypertension

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 2,004 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,004
试验地点
1
主要终点
Rate of nonfatal stroke

研究概览

简要总结

To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after 18 years follow up. To identify whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

详细描述

To identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after18 years follow up, then explore the role of risk factors. After assessing the association between BP categories and all-cause mortality and cardiovascular mortality, to analyze the risk for all-cause and cardiovascular mortality by blood glucose categories and BP categories combined by using multiple Cox regression analysis. To analyze the corresponding incidence of all-cause mortality per 1,000 person-years for the BP<130/80 mmHg, 130-139/80-89 mmHg, and ≥140/90 mmHg or treated groups respectively after adjusting for age, sex, and other factors. To identify the associations between cardiovascular mortality and BP categories alone or combined with blood glucose categories were consistent with that of all-cause mortality.

To identify relative metabolic molecular biomarker panel detected by mass spectrometry in blood samples correlating with efficacy in prediabetes and stage 1 hypertension among Chinese adults. Compare the plasma metabolic profiles of different groups and the metabolic markers were screened and optimized by multivariate statistical analysis, logistic regression analysis and receiver operating characteristic (ROC) curve analysis.

To determine whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

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 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged from 18-76 years old
  • lived in Shanghai Pingliang community for 20 years
  • all participants' blood pressures are at baseline

排除标准

  • aged <18 years old or > 76 years old
  • with second primary malignant diseases.
  • other situations assessed by investigator can disturb quality control of the investigation.

结局指标

主要结局

Rate of nonfatal stroke

时间窗: 24 months

Stroke can be divided into ischemic stroke, subarachnoid hemorrhage, cerebral parenchymal hemorrhage, other hemorrhage, other types or unknown types.

Rate of heart failure

时间窗: 24 months

Heart failure is defined as a clinical syndrome characterized by a variety of symptoms and signs of cardiac decompensation / cardiac pump insufficiency that are hospitalized or require infusion in the emergency room.

Rate of nonfatal myocardial infarction

时间窗: 24 months

The diagnosis of myocardial infarction includes clinical manifestations (symptoms and signs), measurement of cardiac biomarkers and ECG interpretation; myocardial infarction occurred during surgery / operation and myocardial infarction terminated due to thrombolytic therapy. According to the available data, the outcome evaluator will classify myocardial infarction into three categories: definite, probable and possible. All three types of myocardial infarction were included in the main outcome. Stroke can be judged based on all available data, including symptoms and signs, brain and large vessel imaging, and cardiac examinations such as echocardiography.

Rate of cardiovascular death

时间窗: 24 months

Cardiovascular death includes stroke, coronary heart disease, heart failure or other forms of cardiovascular disease (such as abdominal aortic aneurysm rupture, arrhythmia, etc.).

次要结局

  • Rate of all-cause death(24 months)
  • Rate of major cardiovascular event composite endpoint(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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