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临床试验/NCT04014153
NCT04014153已完成不适用

The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)

I.M. Sechenov First Moscow State Medical University0 个研究点目标入组 1,023 人开始时间: 2012年5月16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
1,023
主要终点
Overall mortality

研究概览

简要总结

Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.

The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.

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

入选标准

  • Informed consent
  • Male and female patients 18 y. o. and older
  • Verified stable coronary artery disease (CAD)
  • Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media

排除标准

  • Pregnancy, lactation
  • Conditions affecting the prognosis (kidney failure, liver failure, oncology)
  • Acute coronary syndrome (ACS)
  • Contraindications to PCI
  • Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
  • Refusal to sign the informed consent

结局指标

主要结局

Overall mortality

时间窗: 5 years

Stroke

时间窗: 5 years

CABG

时间窗: 5 years

CABG after PCI at enrolment

GI bleeding

时间窗: 5 years

PCI

时间窗: 5 years

Repeat PCI after the enrolment

Cardiovascular mortality

时间窗: 5 years

Myocardial infarction

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Mironova

Principal Investigator

I.M. Sechenov First Moscow State Medical University

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