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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00689377 |
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Date of registration:
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29/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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9000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00689377 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Belgium
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France
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Greece
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Italy
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Netherlands
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Switzerland
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Contacts
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Name:
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Claudio Cimminiello |
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Address:
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Telephone:
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Email:
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Affiliation:
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Unit of Medicine, Vimercate Hospital - Vimercate (MI) - Italy |
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Name:
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Claudio Borghi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Internal Medicine Dept., di Medicina Interna, Policlinico Universitario Sant'Orsola-Malpighi, Bologna, Italy |
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Name:
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Mario Mangrella |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca S.p.A |
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Name:
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Raffaele Sabia |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca S.p.A. |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Moderate Risk for Cardiovascular Disease (CVD)
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Peripheral Arterial Disease (PAD)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population
[Time Frame: 1 visit]
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Secondary ID(s)
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NIS-CEU-DUM-2006/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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