Peripheral Artery Disease in Vastmanland (PADVa)
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|ClinicalTrials.gov Identifier: NCT01452165|
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : October 14, 2011
The main purposes of this study are:
- to describe the prevalence and degree of reduced left ventricular function and hypertrophy in patients with peripheral arterial disease in comparison to controls from the general population,
- to evaluate factors of importance to left ventricular dysfunction and hypertrophy in patients with peripheral arterial disease, and
- to assess the impact of cardiac function and left ventricular hypertrophy on long-term prognosis in patients with peripheral artery disease.
|Condition or disease|
|Peripheral Vascular Diseases Heart Failure Ventricular Dysfunction|
|Study Type :||Observational|
|Actual Enrollment :||457 participants|
|Official Title:||Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).|
|Study Start Date :||May 2006|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
- Left ventricular ejection fraction (cross-sectional outcome measure) [ Time Frame: baseline ]LVEF obtained by echocardiographic biplane disk summation method. In the cross-sectional study, the mean value of LVEF and the prevalence of reduced LVEF (LVEF < 50%) in the patient group will be compared to the control group.
- Cardiovascular events (longitudinal outcome measure) [ Time Frame: 5-10 years ]Cardiovascular events obtained from the Swedish National Causes of Death register and the Swedish National In-patient register. The registers are linked to the patients by the unique personal identification number assigned to each swedish resident.
- Left ventricular mass (cross-sectional outcome measure) [ Time Frame: baseline ]Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.
- Wall motion score index (WMSI) [ Time Frame: baseline ]Left ventricular wall motion score according to the American Society of Echocardiopgraphy.
- Echocardiographic left ventricular filling variables [ Time Frame: baseline ]Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios).
Biospecimen Retention: Samples With DNA
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): NCT01452165
|Center of Clinical Research, Uppsala university, Central Hospital|
|Västerås, Sweden, SE-72189|
|Principal Investigator:||Pär Hedberg, MD, PhD||Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden|
|Study Chair:||Jerzy Leppert, MD, PhD||Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden|