跳至主要内容
临床试验/NCT01071642
NCT01071642已完成不适用

The Influence of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Renal Function in Patients Undergoing Non-emergent Coronary Angiography

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in eGFR from baseline to 48 hours following the exposure to the contrast.

研究概览

简要总结

The aim of the current study is to evaluate prospectively whether concomitant administration of RAAS blockers (namely ACE-I and ARBs') influence the change in estimated GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years
  • Subjects on chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file)
  • Subjects planned to undergo non-emergent coronary angiography.
  • Signed informed consent

排除标准

  • eGFR<30 ml/min at baseline
  • Chronic utilization of NSAIDS and Cox-2 selective inhibitors
  • Chronic treatment with mineralocorticosteroid receptor blocker
  • Systolic blood pressure<90 mmHg
  • Planned staged (repeated) procedure within 48 hours
  • Administration of contrast within 14 days prior to the enrollment
  • contraindication to stop ACE-I or ARB'S

研究组 & 干预措施

group b

Active Comparator

干预措施: stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure (Drug)

group c

Active Comparator

干预措施: ACE/ARB stopped 24 hours before procedure and start immediately after (Drug)

结局指标

主要结局

Change in eGFR from baseline to 48 hours following the exposure to the contrast.

时间窗: 48 hours after exposure to the contrast

次要结局

  • 1. Rate of eGFR decrease>25% from the baseline, 2. Length of hospitalization,(48-72 hours after exposure to contrast)

研究者

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

Talya Wolak

senior doctor internal medicine department

Soroka University Medical Center

研究点 (1)

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