Peripheral Artery Disease in Vastmanland

NCT01452165 | Completed DMC

• 1 other identifier: PADVa
• Study Type: observational
• Target: 457
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Diseases; Heart Failure; Ventricular Dysfunction

Keywords

Cardiovascular diseases; Hypertrophy, Left ventricle; Echocardiography; Prognosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Wall motion score index (WMSI)

  baseline

• Echocardiographic left ventricular filling variables

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• age less than 18 years
• severly impaired communication capabilities

Sponsors & Collaborators

• Uppsala University: lead
• Västmanland County Council, Sweden: collaborator

Study Sites (1)

Center of Clinical Research, Uppsala university, Central Hospital

Västerås, SE-72189, Sweden

Location

Related Publications (4)

• 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.

  PMID: 24771615 RESULT

• 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.

  PMID: 29171136 RESULT

• 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.

  PMID: 29796748 RESULT

• Dahle N, Arnlov J, Leppert J, Hedberg P. Nondipping blood pressure pattern predicts cardiovascular events and mortality in patients with atherosclerotic peripheral vascular disease. Vasc Med. 2023 Aug;28(4):274-281. doi: 10.1177/1358863X231161655. Epub 2023 Apr 10.

  PMID: 37036102 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum.

MeSH Terms

Conditions

Peripheral Vascular Diseases; Heart Failure; Ventricular Dysfunction; Cardiovascular Diseases; Hypertrophy

Condition Hierarchy (Ancestors)

Vascular Diseases; Heart Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Pär Hedberg, Assoc. Professor

  Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden

  STUDY CHAIR

• Jerzy Leppert, Senior Professor

  Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

SE (1)