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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689377

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:	Case-Only, 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:

MedlinePlus related topics: Diabetes Vascular Diseases

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 ]

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated 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 336 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

Responsible Party:	AstraZeneca S.p.A ( Raffaele Sabia, MD, VP R&D, AstraZeneca S.p.A )
Study ID Numbers:	NIS-CEU-DUM-2006/1
Study First Received:	May 29, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00689377 History of Changes
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:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010