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临床试验/NCT03488823
NCT03488823已完成不适用

Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.

Klinik für Kardiologie, Pneumologie und Angiologie2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月1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
发起方
入组人数
40
试验地点
2
主要终点
Increase of Endothelial Function of Arteria radialis

研究概览

简要总结

With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • planed catheterization, that has be done via Arteria radialis

排除标准

  • acute infection (CRP>0.5 mg/dl)
  • malignant diseases
  • heart failure (NYHA III-IV)
  • renal failure (GFR<60 ml/min)
  • profoundly atrial fibrilation
  • hypotension (≤100/60 mmHg)
  • intolerance of nitroglycerin

研究组 & 干预措施

Young with Flavanol

Experimental

Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).

干预措施: with Flavanol (Dietary Supplement)

Young without Flavanol

Placebo Comparator

Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols .

干预措施: without Flavanol (Dietary Supplement)

Old with Flavanol

Experimental

Old patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).

干预措施: with Flavanol (Dietary Supplement)

Old without Flavanol

Placebo Comparator

Young patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols.

干预措施: without Flavanol (Dietary Supplement)

结局指标

主要结局

Increase of Endothelial Function of Arteria radialis

时间窗: week 2

Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization

次要结局

  • Degree of intimal Injury after Catheterization(1 month)

研究者

发起方
Klinik für Kardiologie, Pneumologie und Angiologie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Principle Investigator

Heinrich-Heine University, Duesseldorf

研究点 (2)

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