Peripheral Artery Disease in Vastmanland

Completed

• Conditions: Peripheral Vascular Diseases; Heart Failure; Ventricular Dysfunction

• Registration Number: NCT01452165
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (cross-sectional outcome measure)	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)	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)	baseline	Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center of Clinical Research, Uppsala university, Central Hospital; 🇸🇪 Västerås, Sweden