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临床试验/NCT04936867
NCT04936867已完成不适用

The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Survival

研究概览

简要总结

In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.

Particular aims include:

  1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models

  2. To determine associations between CAD severity and plaque type and:

  3. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)

  4. blood markers of increased cardiovascular risk

  5. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)

  6. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

详细描述

Particular aims include:

  1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models

  2. To determine associations between CAD severity and plaque type and:

  3. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)

  4. blood markers of increased cardiovascular risk

  5. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)

  6. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

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
否

入选标准

  • •Adults (=/>18 years of age)
  • •Able to provide informed consent
  • •Clinical indication for cardio-CT in line with the latest clinical guidelines

排除标准

  • •standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
  • •known allergy to iodinated contrast agent
  • •suspected acute kidney injury
  • •unstable hemodynamic status or arrhythmias
  • •suspected acute coronary syndrome
  • •manifest thyrotoxicosis

结局指标

主要结局

Survival

时间窗: 5 year

number of deaths

Survival

时间窗: 2 year

number of deaths

次要结局

未报告次要终点

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Puentmann

Clinical professor

Johann Wolfgang Goethe University Hospital

研究点 (1)

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