Clinical trial NCT01452165: Peripheral Artery Disease in Vastmanland
Official title: Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Diseases
Heart Failure
Ventricular Dysfunction
Keywords: Cardiovascular diseases
Hypertrophy, Left ventricle
Echocardiography
Prognosis
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Västmanland County Council, Sweden
First posted: 2011-10-14
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients referred to the Ultrasound laboratory of the Vascular Surgery Department for evaluation of known or suspected vascular disease.

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.

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

Primary outcomes:
measure: Left ventricular ejection fraction (cross-sectional outcome measure)
timeFrame: baseline
measure: Cardiovascular events (longitudinal outcome measure)
timeFrame: 5-10 years
measure: Left ventricular mass (cross-sectional outcome measure)
timeFrame: baseline
Secondary outcomes:
measure: Wall motion score index (WMSI)
timeFrame: baseline
measure: Echocardiographic left ventricular filling variables
timeFrame: baseline
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Center of Clinical Research, Uppsala university, Central Hospital
Study officials:
affiliation: Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
name: Pär Hedberg, Assoc. Professor
role: STUDY_CHAIR
affiliation: Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
name: Jerzy Leppert, Senior Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedberg P, Hammar C, Selmeryd J, Viklund J, Leppert J, Hellberg A, Henriksen E. Left ventricular systolic dysfunction in outpatients with peripheral atherosclerotic vascular disease: prevalence and association with location of arterial disease. Eur J Heart Fail. 2014 Jun;16(6):625-32. doi: 10.1002/ejhf.95. Epub 2014 Apr 26.
citation: Hysing P, Jonason T, Leppert J, Hedberg P. Prevalence and prognostic impact of electrocardiographic abnormalities in outpatients with extracardiac artery disease. Clin Physiol Funct Imaging. 2018 Sep;38(5):823-829. doi: 10.1111/cpf.12488. Epub 2017 Nov 24.
citation: Nowak C, Carlsson AC, Ostgren CJ, Nystrom FH, Alam M, Feldreich T, Sundstrom J, Carrero JJ, Leppert J, Hedberg P, Henriksen E, Cordeiro AC, Giedraitis V, Lind L, Ingelsson E, Fall T, Arnlov J. Multiplex proteomics for prediction of major cardiovascular events in type 2 diabetes. Diabetologia. 2018 Aug;61(8):1748-1757. doi: 10.1007/s00125-018-4641-z. Epub 2018 May 24.