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临床试验/NCT05647577
NCT05647577进行中(未招募)不适用

Prevalence and Risk Factors Associated With Cardiac Comorbidity in Inflammatory Arthritis - A Prospective Cohort Study

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 1,285 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,285
试验地点
1
主要终点
Myocardial infarction

研究概览

简要总结

The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are:

  • Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP).
  • In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA

Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram.

Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.

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

  • Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis

排除标准

  • Persons not able to cooperate
  • Persons unable understand and sign "informed consent"

结局指标

主要结局

Myocardial infarction

时间窗: 10 years

Cardiovascular mortality

时间窗: 10 year outcome

Admission with congestive heart failure

时间窗: 10 years

Revascularization

时间窗: 10-year follow-up

Percutaneous coronary intervention or coronary artery bypass graft

Incident Heart Failure

时间窗: 10-year follow-up

Incident valvular disease

时间窗: 10-year follow-up

次要结局

未报告次要终点

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Biering-Sørensen

Professor in Translational Cardiology and Pragmatic Randomized Trials

University Hospital, Gentofte, Copenhagen

研究点 (1)

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