跳至主要内容
临床试验/NCT01527344
NCT01527344已完成不适用

Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
82
试验地点
1
主要终点
Characterize CAV in-vivo with OCT

研究概览

简要总结

Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • patients aged 18 or older
  • patients with cardiac transplant undergoing routine CAV surveillance

排除标准

  • patients < 18 years old
  • patients with acute rejection
  • patients with active infection
  • patients with chronic renal insufficiency with a glomerular filtration rate (GFR) < 30ml/min
  • patients not able to give informed consent

结局指标

主要结局

Characterize CAV in-vivo with OCT

时间窗: 1 year

次要结局

  • Predict the presence and severity of CAV with peripheral endothelial function scores(1 year)
  • Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH(1 year)
  • Predict the presence and severity of CAV with absolute counts of EPCs.(1 year)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Lerman

MD

Mayo Clinic

研究点 (1)

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