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

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ClinicalTrials.gov Identifier: NCT00689377
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Peripheral Arterial Disease (PAD) Moderate Risk for Cardiovascular Disease (CVD)

Study Design

Study Type : Observational
Actual Enrollment : 9000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus
Study Start Date : May 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population [ Time Frame: 1 visit ]

Eligibility Criteria

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689377


  Show 334 Study Locations
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00689377     History of Changes
Other Study ID Numbers: NIS-CEU-DUM-2006/1
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by AstraZeneca:
Peripheral Arterial Disease (PAD)
Cardiovascular Disease (CVD)
Atherosclerotic cardiovascular disease
Atherosclerosis
Primary CVD prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases