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Clinical Trials/NCT03488823
NCT03488823
Completed
Not Applicable

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

Klinik für Kardiologie, Pneumologie und Angiologie1 site in 1 country40 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Enrollment
40
Locations
1
Primary Endpoint
Increase of Endothelial Function of Arteria radialis
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
April 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible Party
Sponsor Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Principle Investigator

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

Inclusion Criteria

  • planed catheterization, that has be done via Arteria radialis

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Increase of Endothelial Function of Arteria radialis

Time Frame: week 2

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

Secondary Outcomes

  • Degree of intimal Injury after Catheterization(1 month)

Study Sites (1)

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