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Completed

NCT Number: NCT01452165

Peripheral Artery Disease in Vastmanland

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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Heart Diseases Heart Failure Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center of Clinical Research, Uppsala university, Central Hospital

Västerås, SE-72189, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Left ventricular ejection fraction (cross-sectional outcome measure)

    Time frame: 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.

  2. Cardiovascular events (longitudinal outcome measure)

    Time frame: 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.

  3. Left ventricular mass (cross-sectional outcome measure)

    Time frame: baseline

    Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.

Secondary outcomes

  1. Wall motion score index (WMSI)

    Time frame: baseline

    Left ventricular wall motion score according to the American Society of Echocardiopgraphy.

  2. Echocardiographic left ventricular filling variables

    Time frame: baseline

    Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios).

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Västmanland County Council, Sweden

Registry information

Official study title

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

Acronym: PADVa

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2011
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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