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临床试验/NCT01344434
NCT01344434已完成不适用

Angiographic CT of Renal Transplantation Candidate - Study

University of Aarhus1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
167
试验地点
1
主要终点
To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates.

研究概览

简要总结

This study hypothesizes that renal transplantation candidates are diagnosed with significant Coronary Artery Disease (CAD) equal with non-invasive modalities as with invasive modalities. Therefore the investigators are investigating the ability of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).

详细描述

Chronic kidney disease is a known risk factor for cardiovascular disease and cardiovascular disease is the leading cause of mortality in end-stage renal disease (ESRD) patients. After renal transplantation one-half of all deaths are cardiac, usually in the first 5 years in the presence of a functional graft. Because of this renal transplantation candidates are undergoing cardiac pre-transplant risk stratification.

There is no consensus regarding which modality should be use for detection of CAD in this cardiac pre-transplant risk stratification. CAG is known as gold standard but is a invasive procedure with risk of complication.

The investigators wish to investigate the ability of detecting CAD as defined by invasive Coronary angiography (CAG) by clinical examination, blood test and non-invasive test (cCTA, MPS and acoustic CAD Patch). The investigators hypothesize that a single modality or combination of these with high sensitivity and specificity could diagnose significant CAD without the need of further invasive procedures.

This study will include 150 renal transplantations candidate.

研究设计

研究类型
Observational
时间视角
Retrospective

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

  • Endstage renal disease
  • Preparing for renal transplantation
  • Indication for CAG

排除标准

  • Known allergy to iodinated contrast
  • Women who are pregnant or nursing
  • Severe mental illness

结局指标

主要结局

To investigate the ability of non-invasive tests to detect CAD as defined by invasive angiography in renal transplantation candidates.

时间窗: 2013 october

Baseline results of coronary computed tomographic angiography (cCTA), myocardial perfusion scintigraphy (MPS), acoustic CAD Patch and combination hereof to detect CAD as defined by invasive Coronary angiography (CAG).

次要结局

  • To investigate the risk of Contrast-Induced Nephropathy (CIN) after cCTA and CAG.(2013 october)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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