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The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA)

2016年9月16日 更新者:James L. Januzzi、Massachusetts General Hospital

The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study

The purpose of this research is to determine the relationship between novel blood tests for heart function (including hormones and heart enzymes measured in the blood), and assess for kidney damage before and after angiography (cardiac catheterization). We hypothesize that these novel tests will enable us to predict possible complications of catheterization immediately after the procedure.

研究概览

详细说明

The purpose of this research is to determine the relationship between (novel) cardiac and renal biomarkers before and after angiography. Clearly, having data immediately forewarning the clinician that cardiomyocyte injury has occurred, or that impending renal failure is ahead would allow for therapeutic intervention to reduce the likelihood for severe complications, and would ultimately pave the way for opportunities to derive methods to better prevent these complications. With the rapid evolution of organ-specific markers of injury comes an opportunity to explore new venues for their application.

With respect to myocardial injury, a new highly sensitive troponin molecule testing assays have recently been validated which enables to detect extremely small concentrations of troponin released in the circulation. With these assays, it may be possible to detect possible troponin release as early as minutes after injury has occurred.

Accordingly, as a primary goal of the CASABLANCA study, we will examine the release of high sensitivity troponin assays during catheterization and correlate with clinical and standard biochemical measures in order to see if a gradient of change during catheterization would be associated with subsequent recognition of peri-procedural myocardial infarction; it is the expectation that ultra high-sensitivity troponin methods will allow for nearly immediate recognition of complications following heart catheterization, when compared to the standard, non-high sensitivity methods currently in use.

With regards to peri-procedural renal injury, at present, several serum markers are being studied as potential markers or predictors in contrast induced nephropathy (CIN): Neutrophil gelatinase-associated lipocalin (NGAL) is highly accumulated in the kidney cortical tubules and leaks into the circulation after nephrotoxic and ischemic injuries. Up-regulation of the neutrophil adhesion receptor CD11b has also been associated with acute renal injury after cardiac surgery, while carbamylated hemoglobin performed quite well in differentiating acute kidney injury from elevated creatinine due to chronic kidney disease. Finally, Cystatin-C has shown to have a good accuracy for the early diagnosis of acute kidney injury before the clinical diagnosis as well.

In addition, blood will be stored for future testing of novel and experimental biomarkers in 'bench-to-bedside' collaborations, as a final yet crucial step in translational research.

研究类型

观察性的

注册 (实际的)

1298

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

1250 patients undergoing angiography as clinical standard (diagnostic or therapeutic) care;

描述

Inclusion Criteria:

  • evaluation for possible or confirmed coronary artery disease with or without intervention
  • evaluation of cerebrovascular and/or peripheral artery disease with or without intervention

Exclusion Criteria:

  • Inability or unwillingness to participate
  • Procedures without angiographic procedures

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
major cardiovascular event
大体时间:1 year follow up
1 year follow up

次要结果测量

结果测量
大体时间
renal dysfunction
大体时间:1 year
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年9月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2009年2月10日

首先提交符合 QC 标准的

2009年2月11日

首次发布 (估计)

2009年2月12日

研究记录更新

最后更新发布 (估计)

2016年9月19日

上次提交的符合 QC 标准的更新

2016年9月16日

最后验证

2016年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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