跳至主要内容
临床试验/NCT03326167
NCT03326167
终止
不适用

Determination of Coronary Flow Reserve by Dynamic Myocardial Perfusion Scintigraphy

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 15 人2017年11月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Coronary Heart Disease
发起方
Hospices Civils de Lyon
入组人数
15
试验地点
1
主要终点
Presence of significant stenosis in each of the three coronary areas
状态
终止
最后更新
3年前

概览

简要总结

Because of its availability, non-invasiveness, and high diagnostic performance, myocardial perfusion tomoscintigraphy has become a standard tool for the detection, characterization and monitoring of coronary artery disease. Standard analysis, based on the reversibility of regional myocardial hypoperfusion between stress (physiological or pharmacological) and rest, has good sensitivity and negative predictive value in the search for myocardial ischemia. However, two major obstacles persist. First, because of the relative nature of the normalization of cardiac activity, this approach may underestimate the extent of the damage, especially when the territory with the most activity is itself pathological. Thus myocardial perfusion scintigraphy can only detect 40 to 50% of tri-truncal patients. To overcome these disadvantages, several indexes have been proposed to improve the diagnostic performance of perfusion scintigraphy in multi-truncal patients based in particular on kinetic analysis. Secondly, the review does not provide any guarantee as to the quality and reproducibility of use of the coronal reserve during stress, in particular during submaximal stress tests and pharmacological stress, the latter being easily antagonized by xanthine derivatives contained in tea and coffee in particular (abstinence of at least 12 to 24 hours being recommended). In recent years and thanks to the advent of CZT semiconductor cameras dedicated to cardiology - to perform a dynamic tomographic acquisition - a study of the coronal reserve is feasible by perfusion tomoscintigraphy in current practice. This study of the coronary reserve mainly consists of a computer post-processing of the myocardial perfusion scintigraphy data and does not therefore require any additional irradiation (the only difference with respect to the old protocols is the start of the images at the time of publication. injection of the radiotracer). However, the diagnostic benefit gained from the coronary reserve study compared to conventional stress / rest perfusion scintigraphy has not been clearly studied, particularly in the multi-truncal patients.

注册库
clinicaltrials.gov
开始日期
2017年11月15日
结束日期
2019年3月13日
最后更新
3年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Patients sent to the Nuclear Medicine Department as part of a functional evaluation by dynamic acquisition tomoscintigraphy and who will benefit from coronary angiography in the Louis Pradel Hospital hemodynamics department, depending on the results and the clinical context , outside of an emergency context.
  • Patients who received the information and did not object to participate in the study

排除标准

  • Patient with a contraindication to pharmacological stress by dipyridamole or regadenoson (acute coronary syndrome, acute pulmonary embolism, hypertension) severe pulmonary artery disease, acute aortic dissection, symptomatic aortic stenosis, hemodynamic instability, acute myocarditis, pericarditis or endocarditis, severe chronic obstructive pulmonary disease, uncompacted type III atrioventricular block, systolic pressure \<90 mmHg, Recent ischemic stroke, hypersensitivity or allergy to active ingredients or excipients)
  • Patients under 18 years of age
  • Patients with atrial fibrillation complete arrhythmia (ACFA)
  • Patients with a history of coronary bypass grafting.
  • Patients whose clinical condition requires rapid management not allowing to wait for the completion of the exams
  • Pregnancy and breast feeding
  • Deprivation of civil rights (guardianship, guardianship, safeguard of justice)

结局指标

主要结局

Presence of significant stenosis in each of the three coronary areas

时间窗: two weeks after MPI SPECT

The gold standard will be provided by coronarography with Fractional Flow Reserve measurement during the angiographic procedure if necessary. Coronary stenosis with Fractional Flow Reserve \<0.8 will be retained as positive

研究点 (1)

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