Flavonols and Endothelial Injury

Study Overview
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Brief Summary
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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.

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

Conditions
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Endothelial Dysfunction

Intervention / Treatment
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* Dietary Supplement: with Flavanol
* Dietary Supplement: without Flavanol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young with Flavanol<br>Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). | Dietary Supplement: with Flavanol<br>* Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.<br>|
| Placebo Comparator: Young without Flavanol<br>Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols . | Dietary Supplement: without Flavanol<br>* Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.<br>|
| Experimental: Old with Flavanol<br>Old patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). | Dietary Supplement: with Flavanol<br>* Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.<br>|
| Placebo Comparator: Old without Flavanol<br>Young patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols. | Dietary Supplement: without Flavanol<br>* Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of Endothelial Function of Arteria radialis | Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization | week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of intimal Injury after Catheterization | Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial Function, Flavonols, Intima Injury