Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention

Peripheral Arterial Disease (PAD) Clinical Trial

— PANDORA  

Official title:

Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689377
• Other study ID #: NIS-CEU-DUM-2006/1
• Status: Completed
• Phase: N/A
• First received: May 29, 2008
• Last updated: March 19, 2012
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéGreece: National Organization of MedicinesItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9000
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Male subject aged 45 years or above, or female subject aged 55 years or above (age-related CVD risk factor)

• At least another of the following risk factor for CVD: cigarette smoking, hypertension, low HDL cholesterol or high LDL cholesterol, family history of premature coronary heart disease, elevated waist circumference

• Willingness to participate in the survey and complying with the study by signing a written informed consent

Exclusion Criteria:

• No or 1 risk factor for CVD; symptoms of PAD; diabetes mellitus; coronary heart disease or equivalents

• No lipid data collected in the last 12 months

• Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study; unwilling or unable to provide informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Moderate Risk for Cardiovascular Disease (CVD)
• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Belgium	Research Site	Aarschot
Belgium	Research Site	Alsemberg
Belgium	Research Site	Anderlecht
Belgium	Research Site	Anthee
Belgium	Research Site	Arendonk
Belgium	Research Site	Assenede
Belgium	Research Site	Baisy-Thy
Belgium	Research Site	Bande
Belgium	Research Site	Beringen
Belgium	Research Site	Bertrix
Belgium	Research Site	Beyne-Heusay
Belgium	Research Site	Biesme sous Thuin
Belgium	Research Site	Bruxelles
Belgium	Research Site	Burdinne
Belgium	Research Site	Cerexhe-Heuseux
Belgium	Research Site	Champion
Belgium	Research Site	Chenee	Liege
Belgium	Research Site	De Pinte
Belgium	Research Site	Deurle
Belgium	Research Site	Dolembreux
Belgium	Research Site	Dottignies
Belgium	Research Site	Dour
Belgium	Research Site	Drongen
Belgium	Research Site	Ecaussinnes
Belgium	Research Site	Eeklo
Belgium	Research Site	Eisden
Belgium	Research Site	Eke-Nazareth
Belgium	Research Site	Ekeren
Belgium	Research Site	Ellezelles
Belgium	Research Site	Evergem
Belgium	Research Site	Feluy
Belgium	Research Site	Fleron
Belgium	Research Site	Forest
Belgium	Research Site	Fosses-la-Ville
Belgium	Research Site	Geel
Belgium	Research Site	Gent
Belgium	Research Site	Gent (Sint-Amandsberg)
Belgium	Research Site	Gilly
Belgium	Research Site	Gozee
Belgium	Research Site	Grez-Doiceau
Belgium	Research Site	Gribomont
Belgium	Research Site	Ham
Belgium	Research Site	Hasselt
Belgium	Research Site	Hoboken
Belgium	Research Site	Hooglede
Belgium	Research Site	Koekelberg (Brussl)
Belgium	Research Site	Koksyde
Belgium	Research Site	Kraainem
Belgium	Research Site	Landelies
Belgium	Research Site	Ledeberg (Gent)
Belgium	Research Site	Leopoldsburg
Belgium	Research Site	Lillois
Belgium	Research Site	Linkebeek
Belgium	Research Site	Lommel
Belgium	Research Site	Lustin
Belgium	Research Site	Maasmechelen
Belgium	Research Site	Malmedy
Belgium	Research Site	Marchienne-au-Pont
Belgium	Research Site	Marchovelette
Belgium	Research Site	Melsbroek
Belgium	Research Site	Mettet
Belgium	Research Site	Molenbeek
Belgium	Research Site	Molenbeek St. Jean
Belgium	Research Site	Natoye
Belgium	Research Site	Oosteeklo
Belgium	Research Site	Oostham
Belgium	Research Site	Oud-Turnhout
Belgium	Research Site	Oudenaarde
Belgium	Research Site	Quaregnon
Belgium	Research Site	Rance
Belgium	Research Site	Ransart
Belgium	Research Site	Retie
Belgium	Research Site	Rhode
Belgium	Research Site	Ronquieres
Belgium	Research Site	Rosieres
Belgium	Research Site	Scherpenheuvel
Belgium	Research Site	Seraing
Belgium	Research Site	Sint Martens Latem
Belgium	Research Site	Sint-Agatha-Rode
Belgium	Research Site	Sint-Amandsberg
Belgium	Research Site	Sint-Denijs-Westrem
Belgium	Research Site	Spouwen
Belgium	Research Site	Sprimont
Belgium	Research Site	Steenokkerzeel
Belgium	Research Site	Tessenderlo
Belgium	Research Site	Thuillies
Belgium	Research Site	Thuin
Belgium	Research Site	Tielt
Belgium	Research Site	Turnhout
Belgium	Research Site	Uccle
Belgium	Research Site	Velroux
Belgium	Research Site	Veurne
Belgium	Research Site	Vlimmeren
Belgium	Research Site	Vosselaar
Belgium	Research Site	Waarschoot
Belgium	Research Site	Waremme
Belgium	Research Site	Waterloo
Belgium	Research Site	Weelde
Belgium	Research Site	Wellin
Belgium	Research Site	Wetteren
Belgium	Research Site	Wezembeek
Belgium	Research Site	Willebroek
Belgium	Research Site	Zomergem
France	Research Site	Agde
France	Research Site	Antony
France	Research Site	Arsac
France	Research Site	Aubervilliers
France	Research Site	Baho
France	Research Site	Balma
France	Research Site	Beauzelle
France	Research Site	Berat
France	Research Site	Beziers
France	Research Site	Blois
France	Research Site	Bourg La Reine
France	Research Site	Bourg Les Valence
France	Research Site	Carnon Plage
France	Research Site	Carquefou
France	Research Site	Castets
France	Research Site	Champforgeuil
France	Research Site	Champigny Sur Marne
France	Research Site	Chatillon Coumont
France	Research Site	Collioure
France	Research Site	Colomiers
France	Research Site	Courpiere
France	Research Site	Cremeaux
France	Research Site	Derval
France	Research Site	Domene
France	Research Site	Drancy
France	Research Site	Eyragues
France	Research Site	Fontaine
France	Research Site	Fresnes Sur Escaut
France	Research Site	Gargenville
France	Research Site	Garons
France	Research Site	Goven
France	Research Site	Guerande
France	Research Site	Herbignac
France	Research Site	Houilles
France	Research Site	Hyeres
France	Research Site	Issy Les Moulineaux
France	Research Site	Ivry Sur Seine
France	Research Site	La Baule
France	Research Site	La Courneuve
France	Research Site	La Riche
France	Research Site	Lattes
France	Research Site	Le Coudray Montceaux
France	Research Site	Le Temple de Bretagne
France	Research Site	Lembach
France	Research Site	Longages
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Martigues
France	Research Site	Metz
France	Research Site	Meylan
France	Research Site	Mezel
France	Research Site	Mirabeau
France	Research Site	Montigny Les Metz
France	Research Site	Montpellier
France	Research Site	Mouchin
France	Research Site	Mouvaux
France	Research Site	Nice
France	Research Site	Nimes
France	Research Site	Noisy Le Grand
France	Research Site	Oignies
France	Research Site	Orlienas
France	Research Site	Paris
France	Research Site	Paris Cedex 13
France	Research Site	Pauillac
France	Research Site	Pernes Les Fontaines
France	Research Site	Perols
France	Research Site	Plan de Cuques
France	Research Site	Pontcharra
France	Research Site	Rieumes
France	Research Site	Ris Orangis
France	Research Site	Roanne
France	Research Site	Rosny Sous Bois
France	Research Site	Saint Etienne
France	Research Site	Saint Orens de Gameville
France	Research Site	Saint Ouen
France	Research Site	Saint Sebastien de Morsent
France	Research Site	Saint-galmier
France	Research Site	Sauveterre de Guyenne
France	Research Site	Seraincourt
France	Research Site	St Donat L Herbasse
France	Research Site	St Maur Des Fosses
France	Research Site	St Paul
France	Research Site	Tarascon
France	Research Site	Thizy
France	Research Site	Toulon
France	Research Site	Tours
France	Research Site	Ville
France	Research Site	Villefranche Sur Saone
France	Research Site	Villenave D Ornon
France	Research Site	Villette D Anthon
France	Research Site	Villeurbanne
France	Research Site	Vincennes
France	Research Site	Wittelsheim
Greece	Research Site	Agrinio
Greece	Research Site	Alexandroupoli
Greece	Research Site	Arta
Greece	Research Site	Athens
Greece	Research Site	Athens North 1
Greece	Research Site	Athina
Greece	Research Site	Attika
Greece	Research Site	Attika South
Greece	Research Site	Attiki
Greece	Research Site	Chalkidiki
Greece	Research Site	Chania
Greece	Research Site	Chrisoupoli Kavalas
Greece	Research Site	Corfu
Greece	Research Site	Drama
Greece	Research Site	Giannitsa
Greece	Research Site	Ioannina
Greece	Research Site	Iraklio Kritis
Greece	Research Site	Ithaki
Greece	Research Site	Kalamaria
Greece	Research Site	Kalamata
Greece	Research Site	Karpenisi
Greece	Research Site	Kastoria
Greece	Research Site	Katerini
Greece	Research Site	Kavala
Greece	Research Site	Kilkis
Greece	Research Site	Komotini
Greece	Research Site	Korinthos
Greece	Research Site	Koropi
Greece	Research Site	Kozani
Greece	Research Site	Lakonia
Greece	Research Site	Lamia
Greece	Research Site	Larissa
Greece	Research Site	Nafpaktos
Greece	Research Site	Patra
Greece	Research Site	Pirgos
Greece	Research Site	Ptolemaida
Greece	Research Site	Rest of Salonica
Greece	Research Site	Rethimno
Greece	Research Site	Rodos
Greece	Research Site	Salonica Central East
Greece	Research Site	Salonica Central West
Greece	Research Site	Salonica Suburbs East
Greece	Research Site	Salonica Suburbs West
Greece	Research Site	Serres
Greece	Research Site	Sitia Kritis
Greece	Research Site	Trikala
Greece	Research Site	Tripoli
Greece	Research Site	Veria
Greece	Research Site	Volos
Greece	Research Site	Xalkida
Greece	Research Site	Xanthi
Greece	Research Site	Zakinthos
Italy	Research Site	AL
Italy	Research Site	AR
Italy	Research Site	AT
Italy	Research Site	BA
Italy	Research Site	BO
Italy	Research Site	CE
Italy	Research Site	CO
Italy	Research Site	FI
Italy	Research Site	FR
Italy	Research Site	GR
Italy	Research Site	MI
Italy	Research Site	MN
Italy	Research Site	NU
Italy	Research Site	OG
Italy	Research Site	OR
Italy	Research Site	PE
Italy	Research Site	RC
Italy	Research Site	SA
Italy	Research Site	SR
Italy	Research Site	TO
Italy	Research Site	TP
Italy	Research Site	VI
Italy	Research Site	VT
Netherlands	Research Site	Beek En Donk
Netherlands	Research Site	Beerzerveld
Netherlands	Research Site	Bennebroek
Netherlands	Research Site	Berlicum
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deurne
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Echt
Netherlands	Research Site	Ermelo
Netherlands	Research Site	Hengelo
Netherlands	Research Site	Hoogwoud
Netherlands	Research Site	Huizen
Netherlands	Research Site	Hulst
Netherlands	Research Site	Landgraaf
Netherlands	Research Site	Lichtenvoorde
Netherlands	Research Site	Lieshout
Netherlands	Research Site	Lisse
Netherlands	Research Site	Losser
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Oude Pekela
Netherlands	Research Site	Poortvliet
Netherlands	Research Site	Rijswijk
Netherlands	Research Site	Roelofarendsveen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sgravenzande
Netherlands	Research Site	Soerendonk
Netherlands	Research Site	Spijkenisse
Netherlands	Research Site	Wassenaar
Netherlands	Research Site	Wildervank
Netherlands	Research Site	Woerden
Switzerland	Research Site	Allschwil
Switzerland	Research Site	Balerna
Switzerland	Research Site	Basel
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Brittnau
Switzerland	Research Site	Bulach
Switzerland	Research Site	Camorino
Switzerland	Research Site	Chiasso
Switzerland	Research Site	Claro
Switzerland	Research Site	Coldrerio
Switzerland	Research Site	Dallikon
Switzerland	Research Site	Dornach
Switzerland	Research Site	Dudingen
Switzerland	Research Site	La Tour- de-Peilz
Switzerland	Research Site	Laufenburg
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Lugano
Switzerland	Research Site	Melide
Switzerland	Research Site	Monthey
Switzerland	Research Site	Muttenz
Switzerland	Research Site	Ponte Capriasca
Switzerland	Research Site	Reinach
Switzerland	Research Site	Renens VD
Switzerland	Research Site	Rumlang
Switzerland	Research Site	St-Maurice
Switzerland	Research Site	Stabio
Switzerland	Research Site	Stafa
Switzerland	Research Site	Tesserete
Switzerland	Research Site	Thalwil
Switzerland	Research Site	Vevey
Switzerland	Research Site	Winterthur
Switzerland	Research Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  France,  Greece,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of lower extremities peripheral arterial disease (PAD), in subjects with a moderate CVD risk, with no overt cardiovascular diseases nor diabetes mellitus		1 visit	No
Secondary	Prevalence of cardiovascular risk factors in subjects with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus		1 visit	No
Secondary	Cardiovascular risk level and risk factor treatment in the selected population assessed according to the locally adopted risk charts or algorithms		1 visit	No
Secondary	Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population		1 visit	No