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临床试验/EUCTR2011-003611-37-IT
EUCTR2011-003611-37-IT进行中(未招募)不适用

PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: hydratation vs carbonates to prevent Contrast-Induced Nephropathy in patients undergoing coronary angiography or intervention at risk for Heart Failure (PREVENT-CIN HF). A prospective randomized trial. - PREVENT-CINHF

AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA0 个研究点目标入组 240 人开始时间: 2012年3月7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
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Consecutive patients undergoing coronary angiography, followed or not by coronary revascularization, at Cath Lab of U.O. of Universitary Cardiology AOU Maggiore della Carità”, Novara.
  • An estimated glomerular filtration rate (GFR) of 60 mL/min or less (calculated by applying the Cockroft-Gault formula) before undergoing coronary angiography.
  • An estimated ejection fraction<40% (transthoracic echocardiogram).
  • Severe mitro-aortic valve disease estimated by transthoracic echocardiogram also in the presence of an ejection fraction >40%.
  • Recent episode af acute pulmonary edema.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 140
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Inability to obtain consent.
  • Age lower than 18 years old.
  • Pregnancy.
  • Coronary angiography/or revascularisation in emergency.
  • Serious comorbility (shock, cardiac arrest, trauma, etc.).
  • An estimated ejection fraction >40% (transthoracic echocardiogram).
  • Hystory of contrast intolerance.
  • Kidney transplant.
  • Periprocedural complications within 48h after the procedure.

研究者

发起方
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA

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