Peripheral Artery Disease in Vastmanland (PADVa)
|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|
|Actual Primary Completion Date :||May 2011|
|Actual 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
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|