Peripheral Artery Disease in Vastmanland (PADVa)

May 7, 2020 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
5-10 years
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wall motion score index (WMSI)
Time Frame: baseline
Left ventricular wall motion score according to the American Society of Echocardiopgraphy.
baseline
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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Västmanland County Council, Sweden

Investigators

  • Principal Investigator: Jerzy Leppert, Senior Professor, Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PADVa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe