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

NCT ID: NCT00689377

Last Updated: 2012-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD) Moderate Risk for Cardiovascular Disease (CVD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raffaele Sabia

Role: STUDY_DIRECTOR

AstraZeneca S.p.A.

Mario Mangrella

Role: STUDY_CHAIR

AstraZeneca S.p.A

Claudio Cimminiello

Role: STUDY_CHAIR

Unit of Medicine, Vimercate Hospital - Vimercate (MI) - Italy

Claudio Borghi

Role: STUDY_CHAIR

Internal Medicine Dept., di Medicina Interna, Policlinico Universitario Sant'Orsola-Malpighi, Bologna, Italy

Locations

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Research Site

Chênée, Liege, Belgium

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Aarschot, , Belgium

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Alsemberg, , Belgium

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Anderlecht, , Belgium

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Anthée, , Belgium

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Arendonk, , Belgium

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Assenede, , Belgium

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Baisy-Thy, , Belgium

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Bande, , Belgium

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Beringen, , Belgium

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Bertrix, , Belgium

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Beyne-Heusay, , Belgium

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Biesme-sous-Thuin, , Belgium

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Brussels, , Belgium

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Burdinne, , Belgium

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Cerexhe-Heuseux, , Belgium

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Champion, , Belgium

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De Pinte, , Belgium

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Deurle, , Belgium

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Dolembreux, , Belgium

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Dottignies, , Belgium

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Dour, , Belgium

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Drongen, , Belgium

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Ecaussinnes, , Belgium

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Eeklo, , Belgium

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Eisden, , Belgium

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Eke-Nazareth, , Belgium

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Ekeren, , Belgium

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Ellezelles, , Belgium

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Evergem, , Belgium

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Feluy, , Belgium

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Fléron, , Belgium

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Forest, , Belgium

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Fosses-la-Ville, , Belgium

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Geel, , Belgium

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Gent (Sint-Amandsberg), , Belgium

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Ghent, , Belgium

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Gilly, , Belgium

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Gozée, , Belgium

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Grez-Doiceau, , Belgium

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Gribomont, , Belgium

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Ham, , Belgium

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Hasselt, , Belgium

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Hoboken, , Belgium

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Hooglede, , Belgium

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Koekelberg (Brussl), , Belgium

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Koksijde, , Belgium

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Kraainem, , Belgium

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Landelies, , Belgium

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Ledeberg (Gent), , Belgium

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Leopoldsburg, , Belgium

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Lillois, , Belgium

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Linkebeek, , Belgium

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Lommel, , Belgium

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Lustin, , Belgium

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Maasmechelen, , Belgium

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Malmedy, , Belgium

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Marchienne-au-Pont, , Belgium

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Marchovelette, , Belgium

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Melsbroek, , Belgium

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Mettet, , Belgium

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Molenbeek, , Belgium

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Molenbeek-Saint-Jean, , Belgium

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Natoye, , Belgium

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Oosteeklo, , Belgium

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Oostham, , Belgium

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Oud-Turnhout, , Belgium

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Oudenaarde, , Belgium

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Quaregnon, , Belgium

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Rance, , Belgium

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Ransart, , Belgium

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Retie, , Belgium

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Rode, , Belgium

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Ronquières, , Belgium

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Rosières, , Belgium

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Scherpenheuvel, , Belgium

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Seraing, , Belgium

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Sint-Agatha-Rode, , Belgium

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Sint-Amandsberg, , Belgium

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Sint-Denijs-Westrem, , Belgium

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Sint-Martens-Latem, , Belgium

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Spouwen, , Belgium

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Sprimont, , Belgium

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Steenokkerzeel, , Belgium

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Thuillies, , Belgium

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Thuin, , Belgium

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Tielt, , Belgium

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Turnhout, , Belgium

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Uccle, , Belgium

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Velroux, , Belgium

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Veurne, , Belgium

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Vlimmeren, , Belgium

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Vosselaar, , Belgium

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Waarschoot, , Belgium

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Waremme, , Belgium

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Waterloo, , Belgium

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Weelde, , Belgium

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Wellin, , Belgium

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Wetteren, , Belgium

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Wezembeek, , Belgium

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Willebroek, , Belgium

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Zomergem, , Belgium

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Agde, , France

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Antony, , France

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Arsac, , France

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Aubervilliers, , France

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Baho, , France

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Balma, , France

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Beauzelle, , France

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Béziers, , France

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Blois, , France

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Bourg-lès-Valence, , France

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Carnon-Plage, , France

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Carquefou, , France

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Castets, , France

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Champforgeuil, , France

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Champigny-sur-Marne, , France

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Chatillon Coumont, , France

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Collioure, , France

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Derval, , France

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Lattes, , France

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Le Temple-de-Bretagne, , France

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Lembach, , France

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Longages, , France

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Lyon, , France

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Marseille, , France

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Martigues, , France

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Metz, , France

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Meylan, , France

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Mezel, , France

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Mirabeau, , France

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Montigny-lès-Metz, , France

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Montpellier, , France

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Mouchin, , France

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Mouvaux, , France

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Nice, , France

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Nîmes, , France

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Noisy-le-Grand, , France

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Oignies, , France

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Orliénas, , France

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Paris, , France

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Pauillac, , France

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Pernes-les-Fontaines, , France

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Pérols, , France

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Plan-de-Cuques, , France

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Pontcharra, , France

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Rieumes, , France

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Ris-Orangis, , France

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Roanne, , France

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Rosny-sous-Bois, , France

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Saint Donat L Herbasse, , France

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Saint-Etienne, , France

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Saint-Galmier, , France

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Saint-Maur-des-Fossés, , France

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Saint-Orens-de-Gameville, , France

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Saint-Ouen, , France

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Saint-Paul-lès-Dax, , France

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Saint-Sébastien-de-Morsent, , France

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Sauveterre-de-Guyenne, , France

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Seraincourt, , France

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Tarascon, , France

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Thizy, , France

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Toulon, , France

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Tours, , France

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Villefranche-sur-Saône, , France

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Villenave-d'Ornon, , France

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Villette-d'Anthon, , France

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Villeurbanne, , France

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Villé, , France

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Vincennes, , France

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Wittelsheim, , France

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Agrinio, , Greece

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Alexandroupoli, , Greece

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Arta, , Greece

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Athens, , Greece

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Athens North 1, , Greece

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Attika South, , Greece

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Attiki, , Greece

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Chalkidiki, , Greece

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Chania, , Greece

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Chrisoupoli Kavalas, , Greece

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Corfu, , Greece

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Corinth, , Greece

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Drama, , Greece

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Giannitsá, , Greece

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Ioannina, , Greece

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Iraklio Kritis, , Greece

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Itháki, , Greece

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Kalamaria, , Greece

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Kalamata, , Greece

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Karpenisi, , Greece

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Kastoria, , Greece

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Katerini, , Greece

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Kavala, , Greece

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Kilkis, , Greece

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Koropí, , Greece

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Kozani, , Greece

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Lamia, , Greece

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Larissa, , Greece

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Nafpaktos, , Greece

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Pátrai, , Greece

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Pírgos, , Greece

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Ptolemaida, , Greece

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Rethymno, , Greece

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Rhodes, , Greece

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Salonica Central East, , Greece

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Salonica Central West, , Greece

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Salonica Suburbs West, , Greece

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Serres, , Greece

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Sitia Kritis, , Greece

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Trikala, , Greece

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Tripoli, , Greece

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Véria, , Greece

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Volos, , Greece

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Xalkida, , Greece

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Xánthi, , Greece

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Zakynthos, , Greece

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AL, , Italy

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AR, , Italy

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's-Hertogenbosch, , Netherlands

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Beek en Donk, , Netherlands

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Beerzerveld, , Netherlands

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Bennebroek, , Netherlands

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Berlicum, , Netherlands

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Deurne, , Netherlands

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Dordrecht, , Netherlands

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Echt, , Netherlands

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Ermelo, , Netherlands

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Hengelo, , Netherlands

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Hoogwoud, , Netherlands

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Huizen, , Netherlands

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Hulst, , Netherlands

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Landgraaf, , Netherlands

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Lichtenvoorde, , Netherlands

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Lieshout, , Netherlands

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Losser, , Netherlands

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Nijmegen, , Netherlands

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Oude Pekela, , Netherlands

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Poortvliet, , Netherlands

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Rijswijk, , Netherlands

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Roelofarendsveen, , Netherlands

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Rotterdam, , Netherlands

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Soerendonk, , Netherlands

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Spijkenisse, , Netherlands

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The Hague, , Netherlands

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Wassenaar, , Netherlands

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Wildervank, , Netherlands

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Woerden, , Netherlands

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Allschwil, , Switzerland

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Balerna, , Switzerland

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Basel, , Switzerland

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Bellinzona, , Switzerland

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Brittnau, , Switzerland

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Bülach, , Switzerland

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Camorino, , Switzerland

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Chiasso, , Switzerland

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Claro, , Switzerland

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Coldrerio, , Switzerland

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Dallikon, , Switzerland

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Dornach, , Switzerland

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Düdingen, , Switzerland

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La Tour-de-Peilz, , Switzerland

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Laufenburg, , Switzerland

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Lausanne, , Switzerland

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Lugano, , Switzerland

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Melide, , Switzerland

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Monthey, , Switzerland

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Muttenz, , Switzerland

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Ponte Capriasca, , Switzerland

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Reinach, , Switzerland

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Renens VD, , Switzerland

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Rümlang, , Switzerland

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St-Maurice, , Switzerland

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Stabio, , Switzerland

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Stäfa, , Switzerland

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Tesserete, , Switzerland

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Thalwil, , Switzerland

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Vevey, , Switzerland

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Winterthur, , Switzerland

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Zurich, , Switzerland

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Countries

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Belgium France Greece Italy Netherlands Switzerland

References

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Sanna G, Alesso D, Mediati M, Cimminiello C, Borghi C, Fazzari AL, Mangrella M; PANDORA study investigators. Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus). BMC Cardiovasc Disord. 2011 Oct 7;11:59. doi: 10.1186/1471-2261-11-59.

Reference Type DERIVED
PMID: 21981988 (View on PubMed)

Cimminiello C, Borghi C, Kownator S, Wautrecht JC, Carvounis CP, Kranendonk SE, Kindler B, Mangrella M; PANDORA Study Investigators. Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study. BMC Cardiovasc Disord. 2010 Aug 5;10:35. doi: 10.1186/1471-2261-10-35.

Reference Type DERIVED
PMID: 20687927 (View on PubMed)

Other Identifiers

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NIS-CEU-DUM-2006/1

Identifier Type: -

Identifier Source: org_study_id

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