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OpenTrials
Completed

NCT Number: NCT03488823

Flavonols and Endothelial Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

with Flavanol

Dietary Supplement

Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.

without Flavanol

Dietary Supplement

Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Primary outcomes

  1. 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

  1. Degree of intimal Injury after Catheterization

    Time frame: 1 month

    Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization

Other outcomes

  1. Microvascular Function

    Time frame: 1 month

    Microvascular Function of Endothelium will be measured with Laser-Doppler Examination 1 month after catheterization

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Acronym: Radialis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2018
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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