NCT03488823

Flavonols and Endothelial Injury

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endothelial Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	with Flavanol	Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.
DIETARY_SUPPLEMENT	without Flavanol	Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2018-04-05
• Last updated: 2018-05-15

Locations

1 site across 1 country: Germany