Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- Uppsala University
- Enrollment
- 457
- Locations
- 1
- Primary Endpoint
- Left ventricular ejection fraction (cross-sectional outcome measure)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
Left ventricular dysfunction is often a consequence of coronary heart disease (CHD). CHD is prevalent among patients with peripheral artery disease. However, there is limited data regarding left ventricular morphology and function in those patients. In the cross-sectional part of this study we will describe the prevalence of reduced cardiac function and left ventricular hypertrophy in a cohort of patients with peripheral artery disease. The patient outcomes will be compared to control subjects randomly selected from the general population in a case-control design. Further, clinical and genetic determinants of cardiac dysfunction in the patient cohort will be identified. In the longitudinal part of the study, the impact of cardiac function and morphology on cardiovascular mortality and morbidity will be evaluated in the cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Fulfillment of at least one of the following criteria:
- •ankle-brachial-index (ABI) \<= 0.9, or
- •stenosis of \> 30% of the internal carotid artery, or
- •symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination.
Exclusion Criteria
- •age less than 18 years
- •severly impaired communication capabilities
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Wall motion score index (WMSI)(baseline)
- Echocardiographic left ventricular filling variables(baseline)