Peripheral Artery Disease in Vastmanland

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01452165

Acronym

PADVa

Enrollment

457

Registered

2011-10-14

Start date

2006-05-31

Completion date

2011-05-31

Last updated

2020-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Peripheral Vascular Diseases, Ventricular Dysfunction

Keywords

Cardiovascular diseases, Hypertrophy, Left ventricle, Echocardiography, Prognosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Sweden

Outcome results