Clinical trial NCT00689377: Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention
Official title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 9000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of lower extremities peripheral arterial disease (PAD), in subjects with a moderate CVD risk, with no overt cardiovascular diseases nor diabetes mellitus
timeFrame: 1 visit
Secondary outcomes:
measure: Prevalence of cardiovascular risk factors in subjects with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus
timeFrame: 1 visit
measure: Cardiovascular risk level and risk factor treatment in the selected population assessed according to the locally adopted risk charts or algorithms
timeFrame: 1 visit
measure: Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population
timeFrame: 1 visit
Other outcomes:
Locations:
city: Chenee
country: Belgium
facility: Research Site
state: Liege
city: Aarschot
country: Belgium
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city: Claro
country: Switzerland
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city: Coldrerio
country: Switzerland
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country: Switzerland
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city: Dornach
country: Switzerland
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country: Switzerland
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Study officials:
affiliation: AstraZeneca S.p.A.
name: Raffaele Sabia
role: STUDY_DIRECTOR
affiliation: AstraZeneca S.p.A
name: Mario Mangrella
role: STUDY_CHAIR
affiliation: Unit of Medicine, Vimercate Hospital - Vimercate (MI) - Italy
name: Claudio Cimminiello
role: STUDY_CHAIR
affiliation: Internal Medicine Dept., di Medicina Interna, Policlinico Universitario Sant'Orsola-Malpighi, Bologna, Italy
name: Claudio Borghi
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.