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NCT00487617 Clinical Trial

Arteriopathy and Endothelial Function

Peripheral Arterial Disease Clinical Trial

Official title:
Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00487617
Other study ID # 3801
Secondary ID
Status Recruiting
Phase N/A
First received June 15, 2007
Last updated February 24, 2009
Start date July 2007
Est. completion date April 2012

Study information
Verified date February 2009
Source University Hospital, Strasbourg, France
Contact Olivier Rouyer, MD
Phone 33.3.88.11.61.22
Email olivier.rouyer@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date April 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Peripheral arteriopathy

- Stable cardio-respiratory status

Exclusion Criteria:

- Dialysis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

Locations
Country Name City State
France Service de Chirurgie Vasculaire Strasbourg
France Service de Physiologie et d'Explorations Fonctionnelles Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial function 1 hour after taking the juice 1 hour after taking the juice No
Secondary Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years 3 years No
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