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临床试验/NCT02638727
NCT02638727Unknown不适用

Assessment of Short-term Effect of L-Citrulline on Endothelial Function and Vasodilation in Known CAD Patients:A Randomized Crossover Clinical Trial

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
improvement of flow mediated dilation to nitroglycerin dependent vasodilation

研究概览

简要总结

The purpose of this study is to determine the efficacy of oral L-Citrulline on endothelial function and vasodilation in patients with coronary artery disease(CAD) by evaluating the brachial artery diameter in the antecubital area by ultrasonography.

详细描述

Before prescribing the drug or placebo, the patients were evaluated via the ultrasound machine equipped. The brachial artery diameter in the antecubital area was measured by the ultrasound and was recorded. Then blood pressure cuff was attached on the arm and dilated 50mmhg above the systolic pressure and for 5 minutes remained the same level to induce ischemia at distal tissues until the occurrence of compensatory vasodilatation. Then the brachial artery diameter (as an estimation of FMD) was measured and recorded. After 4 minutes of administration of 2 puffs of nitroglycerin spray, the brachial artery diameter (as an estimation of NMD) was measured.

After 15 days treatment with the L-Citrulline or the placebo, the patients underwent the ultrasonography again and the above assessments were done.

Improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription) is determined as "improvement of flow mediated dilation to nitroglycerin dependent vasodilation" evaluate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • history of documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio less than 1

排除标准

  • no documented CAD; flow mediated dilation to nitroglycerin dependent vasodilation (FMD/NMD)ratio equal /more than 1

研究组 & 干预措施

Drug Arm

Active Comparator

This group treat with L-Citrulline (3 grams per day)

干预措施: L-Citrulline (Drug)

Placebo Arm

Placebo Comparator

this group treat with placebi every day

干预措施: placebo (Drug)

结局指标

主要结局

improvement of flow mediated dilation to nitroglycerin dependent vasodilation

时间窗: 15 days

improvement of FMD to NMD ratio (before L-Citrulline prescription) to FMD to NMD ratio (after L-Citrulline prescription)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Ali Akbarzadeh

sistant proffesor of shahid beheshti university of medical sciences

Shahid Beheshti University of Medical Sciences

研究点 (1)

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