NCT03488823

Flavonols and Endothelial Injury

Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.
Klinik für Kardiologie, Pneumologie und Angiologie·ClinicalTrials.gov·dietary supplementCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Endothelial Dysfunction
Drug/Device/Intervention
with Flavanol
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Funder
Heinrich-Heine University, Duesseldorf
Location
Duesseldorf, Germany
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2017
End date
Apr 30, 2018
Enrollment
40 participants
Primary outcome

Increase of Endothelial Function of Arteria radialis

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.

ICD-10 classifications
Other peripheral vascular diseasesAtherosclerosis of arteries of extremitiesOther specified peripheral vascular diseasesRenovascular hypertensionOther disorders of arteries and arterioles
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03488823
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03488823 through Pure Global AI's free database. This phase not specified trial is sponsored by Klinik für Kardiologie, Pneumologie und Angiologie and is currently Completed. The study focuses on Endothelial Dysfunction. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.