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OpenTrials
Completed

NCT Number: NCT00689377

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

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.

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Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Moderate Risk for Cardiovascular Disease (CVD) Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Chênée, Liege, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PANDORA

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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