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临床试验/NCT00575120
NCT00575120
已完成
不适用

Assessment of Endothelial Function Using Blood Oxygen Level-Dependent MRI (BOLD-MRI)

University of Calgary1 个研究点 分布在 1 个国家目标入组 15 人2007年9月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Endothelial Function
发起方
University of Calgary
入组人数
15
试验地点
1
主要终点
BOLD-MRI signal-intensity
状态
已完成
最后更新
14年前

概览

简要总结

The purpose of this study is to assess the applicability of a new SSFP-based BOLD sensitive MRI sequence in evaluating endothelial function. Endothelial function will be tested in a setting of reactive hyperemia in the forearm. In a setting of ischemia-reperfusion, the effect of transient endothelial function impairment will be tested. Comparison with endothelial function assessment by brachial ultrasound (FMD) and finger tip plethysmography (PAT) will be incorporated.

Hypothesis: BOLD-MRI is a feasible tool to assess endothelial function in the human forearm during reactive hyperemia. There is significant correlation to established flow-mediated dilation (FMD).

详细描述

This is a single center study on healthy volunteers. The subjects will be seen by the study coordinator in the SCMRC to obtain written informed consent and to assess the co-variable data (vitals, medication, history, contraindications for MRI). The study nurse will schedule two visits for endothelial function assessment that are at least one but not more than three weeks apart. Both visits are to be at the same time of day. The initial volunteer will be assigned an endothelial function assessment with MRI first followed by FMD in the endothelial function lab. Subsequent volunteers will alternate assignment to FMD or MRI first to rule out pre-conditioning effects. Simultaneous to FMD assessment, plethysmographic pulse volume will be evaluated with finger probes on the index finger of each hand. Subjects will be studied in a temperature-controlled room with minimal background distraction and in a fasting state for the previous 4 hours. Subjects will also refrain from ingesting caffeine or nicotine in these preceding 4 hours. Each study day volunteers will undergo two endothelial function assessments. The first baseline assessment takes place after a 10 minute accommodation period. The volunteer is then subjected to a 15 minute upper arm tourniquet. The second assessment takes place 15 minutes after the release of the tourniquet. This so called 'ischemia reperfusion' is known to markedly impair endothelial function for approximately one hour without affecting the early bloodflow responses to reactive hyperemia. This effect is reversible and will help to determine the actual endothelial component of measured BOLD signal changes. One day: 2 CMR studies without contrast agent to assess endothelial function during reactive hyperemia. Each will last 15 minutes. A 15 minutes upper arm occlusion with a pressure cuff in between the 2 measurements will be applied. Another day: 2 FMD studies with ultrasound to assess endothelial function during reactive hyperemia. Each will take 15 minutes. Simultaneously a PAT hyperemic index will be measured. A 15 minutes upper arm occlusion with a pressure cuff in between the 2 measurements will be applied. Blood work (fasting glucose, creatinine, lipids, hsCRP), performed by Calgary Labs Services (CLS). The effect of the reperfusion ischemia will be tested by individually comparing the BOLD signal change (BC) at baseline with BC after reperfusion ischemia. Since these are paired, related data a Wilcoxon rank sum test will be performed and a p value \< 0.05 will be regarded as significant. The same will be done for the FMD and PAT index before and after reperfusion ischemia. FMD as the most accepted technique and will be considered as gold standard and a linear regression analysis of FMD with MBC and TBC will be performed. r2-value will be calculated and a value of \> 0.25 will be considered as reasonable of \> 0.5 as good correlation. If the correlation does not appear linear a Spearman's correlation test will be done. The correlations between PAT index and FMD and PAT index and TBC will also be assessed with linear regression analysis.

注册库
clinicaltrials.gov
开始日期
2007年9月
结束日期
2011年9月
最后更新
14年前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

责任方
Principal Investigator
主要研究者

Oliver Strohm

Adunct Research Associate Professor

University of Calgary

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

BOLD-MRI signal-intensity

时间窗: 75 min

次要结局

  • FMD PAT(75 min)

研究点 (1)

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