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

March 19, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • 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
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      • Bruxelles, Belgium
        • Research Site
      • Burdinne, Belgium
        • Research Site
      • 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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      • Fleron, 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, Belgium
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      • Gent (Sint-Amandsberg), Belgium
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      • Gilly, Belgium
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      • Gozee, 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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      • Koksyde, 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 St. 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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      • Rhode, Belgium
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      • Ronquieres, Belgium
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      • Rosieres, Belgium
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      • Scherpenheuvel, Belgium
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      • Seraing, Belgium
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      • Sint Martens Latem, 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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      • Spouwen, Belgium
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      • Sprimont, Belgium
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      • Steenokkerzeel, Belgium
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      • Tessenderlo, 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
        • Research Site
      • Wellin, Belgium
        • Research Site
      • Wetteren, Belgium
        • Research Site
      • Wezembeek, Belgium
        • Research Site
      • Willebroek, Belgium
        • Research Site
      • Zomergem, Belgium
        • Research Site
    • Liege
      • Chenee, Liege, Belgium
        • Research Site
  • France
      • 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, France
        • Research Site
  • Greece
      • 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, Greece
        • Research Site
  • Italy
      • 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, Italy
        • Research Site
  • Netherlands
      • 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, Netherlands
        • Research Site
  • Switzerland
      • 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, Switzerland
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of lower extremities peripheral arterial disease (PAD), in subjects with a moderate CVD risk, with no overt cardiovascular diseases nor diabetes mellitus
Time Frame: 1 visit
1 visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of cardiovascular risk factors in subjects with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus
Time Frame: 1 visit
1 visit
Cardiovascular risk level and risk factor treatment in the selected population assessed according to the locally adopted risk charts or algorithms
Time Frame: 1 visit
1 visit
Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population
Time Frame: 1 visit
1 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Raffaele Sabia, AstraZeneca S.p.A.
  • Study Chair: Mario Mangrella, AstraZeneca S.p.A
  • Study Chair: Claudio Cimminiello, Unit of Medicine, Vimercate Hospital - Vimercate (MI) - Italy
  • Study Chair: Claudio Borghi, Internal Medicine Dept., di Medicina Interna, Policlinico Universitario Sant'Orsola-Malpighi, Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CEU-DUM-2006/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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