Peripheral Artery Disease in Vastmanland

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).

Conditions
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Peripheral Vascular Diseases, Heart Failure, Ventricular Dysfunction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (cross-sectional outcome measure) | 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. | baseline | 
| Cardiovascular events (longitudinal outcome measure) | 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. | 5-10 years | 
| Left ventricular mass (cross-sectional outcome measure) | Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wall motion score index (WMSI) | Left ventricular wall motion score according to the American Society of Echocardiopgraphy. | baseline | 
| Echocardiographic left ventricular filling variables | Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios). | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular diseases, Hypertrophy, Left ventricle, Echocardiography, Prognosis