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临床试验/NCT07327606
NCT07327606招募中不适用

A Prospective Cohort Study on Prognostic Factors in Patients With Cardiovascular-kidney-metabolic Syndrome

Peking University Third Hospital2 个研究点 分布在 1 个国家目标入组 4,526 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
4,526
试验地点
2
主要终点
Major adverse cardiovascular event

研究概览

简要总结

Patients with Cardiovascular-kidney-metabolic syndrome (CKM) will be prospectively enrolled. We will conduct comprehensive analyses, including transcriptomics, proteomics, and metabolomics, using various types of samples such as plasma and whole blood. Adenosine stress echocardiography will be monitored to collect a large amount of data. Long-term follow-up will be conducted, and modern information technology will be utilized to analyze the relationship between different biomarkers and prognosis. Combined with clinical data, we will attempt to construct a predictive model for CKM patients to precisely formulate treatment and follow-up strategies. Demographic and basic clinical information of the study subjects will be collected, including age, gender, height, weight, blood pressure, cardiovascular risk factors (smoking history, alcohol consumption history, blood pressure, lipid levels, glycated hemoglobin, fasting blood glucose, etc.), clinical medication use, and coronary angiography images. During follow-up, changes in risk factor-related indicators such as blood pressure, blood glucose, and lipid levels, medication use, inflammatory markers, and stress echocardiography will be recorded. Plasma and whole blood samples will be collected and stored in a biobank managed by a biospecimen management system. The occurrence of major adverse cardiovascular events (MACE) in all enrolled patients during the follow-up period will be statistically analyzed. This cohort study will follow up with patients for at least 3 years using multiple methods (questionnaires, outpatient follow-up, and telephone calls). Changes in indicators such as MACE occurrence, biochemical markers, echocardiography, carotid ultrasound, and stress echocardiography will be recorded.

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

入选标准

  • 1)Patients who meet the criteria for CKM stages 0-4 were included. 2)Clinical data were complete.

排除标准

  • 1) Presence of infectious diseases during the sample retention period. 2) Presence of autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, vasculitis, etc.
  • 3) Presence of tumors. 4) Patients with an estimated life expectancy of less than 2 years. 5) Patients with known hypersensitivity to adenosine. 6) Patients who cannot follow up regularly. 7) Pregnant or breastfeeding women, and those participating in other clinical trials.

结局指标

主要结局

Major adverse cardiovascular event

时间窗: 3 years

Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and revascularization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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