Peripheral Arterial Disease (PAD)PANDORANCT00689377

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

An observational study of Peripheral Arterial Disease (PAD) and Moderate Risk for Cardiovascular Disease (CVD), run by AstraZeneca at 331 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Peripheral Arterial Disease (PAD), Moderate Risk for Cardiovascular Disease (CVD)
How many people: 9,000 participants
Where: 331 sitesin 6 countries
Study dates: May 2007to Jul 2008
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

331 sites in 6 countries.

Country

City, postcode or hospital

331 sites in 6 countries

Belgium103 sites

Research Site
Aarschot
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Alsemberg
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Anderlecht
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Anthée
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Arendonk
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Assenede
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Baisy-Thy
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Bande
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Beringen
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Bertrix
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Beyne-Heusay
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Biesme-sous-Thuin
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Brussels
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Burdinne
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Cerexhe-Heuseux
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Champion
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Chênée, Liege
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De Pinte
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Deurle
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Dolembreux
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Dottignies
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Dour
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Drongen
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Ecaussinnes
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Eeklo
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Eisden
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Eke-Nazareth
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Ekeren
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Ellezelles
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Evergem
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Feluy
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Fléron
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Forest
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Fosses-la-Ville
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Geel
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Gent (Sint-Amandsberg)
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Ghent
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Gilly
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Gozée
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Grez-Doiceau
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Gribomont
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Ham
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Hasselt
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Hoboken
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Hooglede
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Koekelberg (Brussl)
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Koksijde
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Kraainem
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Landelies
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Ledeberg (Gent)
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Leopoldsburg
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Lillois
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Linkebeek
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Lommel
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Lustin
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Maasmechelen
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Malmedy
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Marchienne-au-Pont
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Marchovelette
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Melsbroek
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Mettet
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Molenbeek
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Molenbeek-Saint-Jean
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Natoye
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Oosteeklo
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Oostham
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Oud-Turnhout
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Oudenaarde
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Quaregnon
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Rance
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Ransart
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Retie
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Rode
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Ronquières
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Rosières
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Scherpenheuvel
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Seraing
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Sint-Agatha-Rode
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Sint-Amandsberg
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Sint-Denijs-Westrem
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Sint-Martens-Latem
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Spouwen
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Sprimont
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Steenokkerzeel
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Tessenderlo
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Thuillies
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Thuin
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Tielt
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Turnhout
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Uccle
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Velroux
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Veurne
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Vlimmeren
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Vosselaar
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Waarschoot
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Waremme
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Waterloo
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Weelde
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Wellin
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Wetteren
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Wezembeek
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Willebroek
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Zomergem

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Castets
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Champigny-sur-Marne
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Collioure
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Cremeaux
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Derval
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Domène
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Drancy
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Eyragues
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Fontaine
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Fresnes-sur-Escaut
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Gargenville
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Garons
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Goven
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Guérande
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Herbignac
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Houilles
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Hyères
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Ivry-sur-Seine
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La Baule-Escoublac
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La Courneuve
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Lattes
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Le Temple-de-Bretagne
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Lembach
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Lyon
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Marseille
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Martigues
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Metz
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Meylan
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Mezel
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Mirabeau
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Montigny-lès-Metz
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Montpellier
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Mouchin
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Mouvaux
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Nice
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Nîmes
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Noisy-le-Grand
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Oignies
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Orliénas
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Paris
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Pauillac
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Pernes-les-Fontaines
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Pérols
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Plan-de-Cuques
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Pontcharra
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Rieumes
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Roanne
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Rosny-sous-Bois
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Saint Donat L Herbasse
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Saint-Etienne
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Saint-Galmier
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Saint-Maur-des-Fossés
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Saint-Orens-de-Gameville
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Saint-Ouen
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Saint-Paul-lès-Dax
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Saint-Sébastien-de-Morsent
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Sauveterre-de-Guyenne
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Seraincourt
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Tarascon
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Thizy
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Toulon
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Tours
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Villé
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Villefranche-sur-Saône
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Villenave-d'Ornon
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Switzerland32 sites

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Netherlands31 sites

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Italy23 sites

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About this study

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

Conditions: Peripheral Arterial Disease (PAD), Moderate Risk for Cardiovascular Disease (CVD)
Keywords: Peripheral Arterial Disease (PAD), Cardiovascular Disease (CVD), Atherosclerotic cardiovascular disease, Atherosclerosis, Primary CVD prevention
Medical subject headings: Peripheral Arterial Disease, Cardiovascular Diseases, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00689377
Study group	Role	What they receive
1		Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jul 2008

First posted3 Jun 2008 (estimated)
Study startMay 2007
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial Disease (PAD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 9,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00689377
Sponsor's protocol ID: NIS-CEU-DUM-2006/1
Acronym: PANDORA
Status last verified: Mar 2012
First submitted: 29 May 2008
Last updated: 20 Mar 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 21981988
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.
PubMed 20687927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Peripheral Arterial Disease (PAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus
ClinicalTrials.gov ID: NCT00689377
Acronym / sponsor ID: PANDORA / NIS-CEU-DUM-2006/1
Conditions: Peripheral Arterial Disease (PAD), Moderate Risk for Cardiovascular Disease (CVD)
Keywords: Peripheral Arterial Disease (PAD), Cardiovascular Disease (CVD), Atherosclerotic cardiovascular disease, Atherosclerosis, Primary CVD prevention
Study type: Observational
Recruitment status: Completed
Enrolment: 9,000 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

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

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

3 secondary outcomes

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
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
Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population
Time frame: 1 visit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
Derived from this study: PubMed 21981988Sanna 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.
Derived from this study: PubMed 20687927Cimminiello 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.

Related trials for Peripheral Arterial Disease (PAD)

Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raffaele Sabia study director

AstraZeneca S.p.A.

Mario Mangrella study chair

AstraZeneca S.p.A

Claudio Cimminiello study chair

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

331 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease (PAD) and Moderate Risk for Cardiovascular Disease (CVD), run by AstraZeneca at 331 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 331 sites in Belgium, France, Greece, Switzerland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689377, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.