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Arteriopathy and Endothelial Function

Primary Purpose

Peripheral Arterial Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Fruit juice or placebo absorption

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Arteriopathy, endothelial function, fruit juice

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Peripheral arteriopathy
Stable cardio-respiratory status

Exclusion Criteria:

Dialysis

Sites / Locations

Service de Chirurgie VasculaireRecruiting
Service de Physiologie et d'Explorations FonctionnellesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

fruit juice

placebo

Arm Description

300 mL of fruit juice

300 mL of fruit juice without polyphenols

Outcomes

Primary Outcome Measures

Endothelial function 1 hour after taking the juice

Secondary Outcome Measures

Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years

Full Information

NCT ID

NCT00487617

First Posted

June 15, 2007

Last Updated

February 24, 2009

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00487617

Brief Title

Arteriopathy and Endothelial Function

Official Title

Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2007 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Arteriopathy, endothelial function, fruit juice

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fruit juice

Arm Type

Experimental

Arm Description

300 mL of fruit juice

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

300 mL of fruit juice without polyphenols

Intervention Type

Procedure

Intervention Name(s)

Fruit juice or placebo absorption

Intervention Description

absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

Primary Outcome Measure Information:

Title

Endothelial function 1 hour after taking the juice

Time Frame

1 hour after taking the juice

Secondary Outcome Measure Information:

Title

Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Peripheral arteriopathy Stable cardio-respiratory status Exclusion Criteria: Dialysis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olivier Rouyer, MD

Phone

33.3.88.11.61.22

olivier.rouyer@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Rouyer, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Service de Chirurgie Vasculaire

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabien Thaveau, MD

Phone

33.3.88.11.60.68

fabien.thaveau@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Fabien Thaveau, MD

First Name & Middle Initial & Last Name & Degree

Nabil Chakfe, MD

First Name & Middle Initial & Last Name & Degree

Jean-Georges Kretz, MD

Facility Name

Service de Physiologie et d'Explorations Fonctionnelles

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Rouyer, MD

Phone

33.3.88.11.61.22

olivier.rouyer@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Olivier Rouyer, MD

First Name & Middle Initial & Last Name & Degree

Bernard Geny, MD

12. IPD Sharing Statement

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Arteriopathy and Endothelial Function

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