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临床试验/NCT07309913
NCT07309913尚未招募不适用

China Atrial Fibrillation With Complex Metabolic Disorders Cohort Study (CAME Cohort)

Xiangya Hospital of Central South University0 个研究点目标入组 3,459 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,459
主要终点
Major Adverse Cardiovascular Events (MACE)

研究概览

简要总结

The number of atrial fibrillation (AF) patients in China is approximately 32.76 million, with a prevalence rate of 2.3%. AF is associated with severe outcomes such as stroke and heart failure. Metabolic disorders (e.g., obesity, diabetes mellitus, dyslipidemia) are closely linked to the onset and prognosis of AF. However, the epidemiological characteristics and disease burden of AF combined with metabolic disorders in China remain unclear. Additionally, the impact of complex multi-dimensional metabolic disorders on AF prognosis requires further investigation, and current clinical guidelines lack targeted management recommendations for this population.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Major Adverse Cardiovascular Events (MACE)

时间窗: From enrollment to the end of follow-up at 5 years

Major Adverse Cardiovascular Events (MACE) - Composite outcome including the following components, all assessed during the entire follow-up period: * All-cause mortality: Defined as any death regardless of cause, confirmed by death certificate, medical records or family report. * Stroke: Defined as acute focal neurological deficit lasting ≥24 hours (or leading to death within 24 hours) due to cerebral infarction or intracerebral hemorrhage, confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI). * Heart failure-related hospitalization: Defined as hospitalization requiring inpatient treatment due to worsening heart failure symptoms (e.g., dyspnea, edema), with objective evidence of heart failure exacerbation (e.g., elevated BNP, pulmonary congestion on chest imaging).

次要结局

  • Cardiovascular mortality(From enrollment to the end of follow-up at 5 years)
  • Cognitive impairment assessed by the Mini-Mental State Examination (MMSE) scale(From enrollment to the end of follow-up at 5 years)
  • Quality of life: Assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire(From enrollment to the end of follow-up at 5 years)
  • Atrial fibrillation (AF) treated with catheter ablation for 2 or more times(From enrollment to the end of follow-up at 5 years)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

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