Radialis: Flavonols and Endothelial Injury

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie (Other)

Overall Status

Completed

CT.gov ID

NCT03488823

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction	Dietary Supplement: with Flavanol Dietary Supplement: without Flavanol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Increase of Endothelial Function of Arteria radialis [week 2]
Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization

Secondary Outcome Measures

Degree of intimal Injury after Catheterization [1 month]
Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf	NRW	Germany	40225

Sponsors and Collaborators

Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

Principal Investigator: Roberto Sansone, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klinik für Kardiologie, Pneumologie und Angiologie, Principle Investigator, Heinrich-Heine University, Duesseldorf

ClinicalTrials.gov Identifier:

NCT03488823

Other Study ID Numbers:

12-012

First Posted:

Apr 5, 2018

Last Update Posted:

May 15, 2018

Last Verified:

May 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Principle Investigator, Heinrich-Heine University, Duesseldorf

Endothelial Function

Flavonols

Intima Injury

Study Results

No Results Posted as of May 15, 2018