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临床试验/NCT04585854
NCT04585854已完成不适用

Effect of Caffeine on Myocardial Oxygenation

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年11月13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
29
试验地点
1
主要终点
Difference in myocardial oxygenation responses

研究概览

简要总结

The purpose of this study is to investigate the impact of caffeine on myocardial oxygenation and other cardiovascular magnetic resonance parameters in healthy controls.

详细描述

Caffeine is presumed to create a confounder with diagnostic imaging. The vasodilatory capacity is considered a key measure for the detection of significant coronary disease with stenosed epicardial arterial conduit vessels and overall microvascular function, including endothelial dysfunction. Twenty nine healthy controls will undergo a baseline cardiovascular magnetic resonance (CMR) exam. Afterwards, participants will consume coffee in the presence of study personnel. This will consist of 3 espresso shots, which will be consumed within 15 minutes. Approximately 2h after coffee consumption the CMR exam will be repeated. The goal will be to investigate the impact of caffeine on myocardial features. In particular the effect on the myocardial oxygenation response to vasodilating and vasoconstricting stimuli.

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

盲法说明

Blinded image analysis

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Ability to give informed consent, documented by signature
  • •Aged 18 to 45

排除标准

  • •MRI Contraindications following current institutional guidelines at the time of the CMR exam
  • •Knowledge or suspicion of pregnancy (verified with a pregnancy test).
  • •Consumption of caffeine 12h prior to the baseline CMR exam (outside of the study protocol).
  • •Known cardiovascular disease, diabetes, severe respiratory disease, obstructive sleep apnea syndrome, chemotherapy and radiation treatment, cerebrovascular and occlusive peripheral vascular disease.

研究组 & 干预措施

Control

Other

Control population who will undergo two cardiovascular magnetic resonance exams: one at rest and one after drinking caffeine.

干预措施: Caffeine (Other)

结局指标

主要结局

Difference in myocardial oxygenation responses

时间窗: Through study completion up to 5 hours, before and after caffeine

Percent (%) Measure of oxygenation-sensitive signal change measured by CMR

次要结局

  • Difference in myocardial time to peak strain(Through study completion up to 5 hours, before and after caffeine)
  • Difference in rate pressure product(Through study completion up to 5 hours, before and after caffeine)
  • Difference in cardiac index(Through study completion up to 5 hours, before and after caffeine)
  • Difference in 4D blood flow(Through study completion up to 5 hours, before and after caffeine)
  • Difference in myocardial strain rate(Through study completion up to 5 hours, before and after caffeine)
  • Difference in myocardial parametric mapping(Through study completion up to 5 hours, before and after caffeine)
  • Difference in ejection fraction(Through study completion up to 5 hours, before and after caffeine)
  • Difference in myocardial peak strain(Through study completion up to 5 hours, before and after caffeine)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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