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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00689377
First received: May 29, 2008
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population [ Time Frame: 1 visit ] [ Designated as safety issue: No ]

Enrollment: 9000
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects of either sex, any race, with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: May 29, 2008
Last Updated: March 19, 2012
Health Authority: France: Direction Générale de la Santé
Greece: National Organization of Medicines
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 19, 2013