跳至主要内容
临床试验/NCT02360150
NCT02360150终止不适用

Evaluation of Myocardial Viability in Late Presentation Myocardial Infarction: Dual Energy Cardiac CT vs. Cardiac MRI.

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
31
试验地点
1
主要终点
Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT

研究概览

简要总结

The purpose of this study is therefore to show that associated with cardiac angiography echocardiography, in myocardial seen late, would provide the information necessary for the decision revascularization, in a timely manner.

This would allow the patient to avoid duplication of tests including risk related to coronary angiography (bleeding complications, stroke ...) and those related to the implantation of coronary stent (stent) without expected earnings in case of non-viability . This would also reduce the length of hospital stay and costs due to numerous reviews.

详细描述

Percutaneous coronary intervention is not recommended in stable patients with late presentation myocardial infarction, and myocardial viability needs to be evaluated before the procedure. The aim of the study is to evaluate the sensibility and specificity of dual-energy CT for the evaluation of myocardial viability in comparison to cardiac MRI.

The experimental procedure is limited to a second CT acquisition performed 10 minutes in dual energy mode.

Sensitivity and Specificity of delayed enhancement >50% of myocardial thickness provided by dual-energy CT will be evaluated in comparison to cardiac MRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Man or woman
  • Major patient
  • Patient with electrical, biological and clinical signs of myocardial infarction, with late presentation (>24 hours)
  • Creatinine clearance (calculated using the Cockcroft (<age 65) or MDRD (> 65 years))formula > 30 ml / min.
  • Affiliation to the french social security scheme.
  • Women of childbearing age: Negative pregnancy test (urine test).
  • Postmenopausal women, menopause confirmation of diagnosis
  • Patient able to understand the spoken and written French.
  • Signature of informed consent

排除标准

  • Collapsus or organ failure requiring urgent care in intensive care unit
  • Arrhythmia and/or non-reducible tachycardia.
  • History of allergic reaction after iodinated contrast medium injection.
  • History of nephrogenic systemic fibrosis.
  • History of claustrophobia
  • Unbalanced asthma.
  • Acute pulmonary edema.
  • Pregnant or breastfeeding women.
  • Clinical signs of thyrotoxicosis.
  • Person placed under judicial protection,
  • Patient suffering from serious psychiatric disease.
  • Patients participating in another clinical trial.
  • Contraindication to MRI

研究组 & 干预措施

second propeller arm scanner

Experimental

The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement to the inclusion visit.

干预措施: second propeller arm scanner (Radiation)

结局指标

主要结局

Number of patient with a possible evaluation of myocardial viability using dual-energy cardiac CT

时间窗: Day 4

To study the sensitivity of dual-energy cardiac CT for the evaluation of myocardial viability, in patients with late presentation myocardial infarction.

次要结局

  • Number of patient with a possible evaluation of myocardial viability using cardiac MRI(Day 4)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluation of Myocardial Viability : Dual Energy... | 临床试验