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临床试验/NCT02857985
NCT02857985已完成不适用

Evaluation of Infarct Size With 3D Rotational Angiography

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年3月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
infarct size measured by RA

研究概览

简要总结

The size of the infarct is particularly important prognostic marker. It is clearly established that the extent of the infarct is not only correlated to mortality, but also long-term adverse events. The evaluation of the infarct size at the acute phase of the disease is therefore an essential clinical tool to adapt the immediate treatment and follow-up of patients. It is therefore crucial to have techniques that are effective, precise, reproducible, and easily performed during the acute phase to quantify the size of the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the standard examinations for the evaluation of infarct size. However, these exams are difficult to perform during the acute phase of the infarct owing to difficulties in monitoring unstable patients and the limited availability of the apparatus. It is for this reason that the investigators would like to investigate the rotational angiography (RA), which is comparable to a scanner in its mode of action but does not require transfer of patients as performed using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty. RA is a radiological technique that uses the system employed for coronagraph, and consists rotating the fixed C-Arm around the patient and acquisition of a series of images that are then reconstituted. The investigators propose to evaluate the size of the infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as possible after RA and the investigators hope to demonstrated that RA allows the measurement of an infarct as precisely as 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
Other
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

  • Admitted for myocardial infarction and fulfilling the following criteria:
  • Transitory or persistent ST elevation
  • Coronary occlusion (TIMI 0) treated by angioplasty or thrombotic acute stenosis treated or not by angioplasty
  • Planned coronarography
  • With social security coverage
  • Not under any legal protection;
  • The consent form signed.

排除标准

  • Patient unconscious or confused;
  • Presenting:
  • cardiogenic shock;
  • or signs of cardiac insufficiency;
  • or sustained cardiac arrhythmia;
  • or atrial fibrillation;
  • or sustained extrasystole;
  • or high degree block;
  • Contraindication for MRI;
  • Known history of hypersensitivity to MRI contrast agent;
  • Risk of pregnancy or proven pregnancy based on interview data;
  • Breast feeding;
  • Patient subject to legal guardianship by a court;
  • Incapacity to express consent;
  • Patient not or badly understanding French.

研究组 & 干预措施

Patient with Myocardial Infarction

Experimental

干预措施: 3D RA (Device)

Patient with Myocardial Infarction

Experimental

干预措施: MRI (Device)

结局指标

主要结局

infarct size measured by RA

时间窗: Day 1

infarct size measured by MRI

时间窗: Day 4

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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