Peripheral Artery Disease in Vastmanland (PADVa)

This study has been completed.
Sponsor:
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01452165
First received: October 11, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Left ventricular wall motion score according to the American Society of Echocardiopgraphy.

  • Echocardiographic left ventricular filling variables [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01452165     History of Changes
Other Study ID Numbers: PADVa
Study First Received: October 11, 2011
Last Updated: October 11, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014