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Peripheral Artery Disease in Vastmanland (PADVa)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01452165
First Posted: October 14, 2011
Last Update Posted: October 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
  Purpose

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.

Condition
Peripheral Vascular Diseases Heart Failure Ventricular Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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 Outcome Measures:
  • Wall motion score index (WMSI) [ Time Frame: baseline ]
    Left ventricular wall motion score according to the American Society of Echocardiopgraphy.

  • 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).


Biospecimen Retention:   Samples With DNA
Whole blood and serum.

Enrollment: 457
Study Start Date: May 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452165


Locations
Sweden
Center of Clinical Research, Uppsala university, Central Hospital
Västerås, Sweden, SE-72189
Sponsors and Collaborators
Uppsala University
Västmanland County Council, Sweden
Investigators
Principal Investigator: Pär Hedberg, MD, PhD Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
Study Chair: Jerzy Leppert, MD, PhD Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
  More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01452165     History of Changes
Other Study ID Numbers: PADVa
First Submitted: October 11, 2011
First Posted: October 14, 2011
Last Update Posted: October 14, 2011
Last Verified: October 2011

Keywords provided by Uppsala University:
Cardiovascular diseases
Hypertrophy, Left ventricle
Echocardiography
Prognosis

Additional relevant MeSH terms:
Heart Failure
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases