Venous Distension in Patients With Aneurysmatic Arterial Disease

March 31, 2017 updated by: Janis Christian Bartelt, Kantonsspital Baselland Bruderholz

Venous Distension in Patients With Aneurysmatic Arterial Disease Compared to the Venous Distension in Patients With Arterial Occlusive Disease

The aim of the study is to assess if venous distension in patients with aneurysmatic arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD) and in controls.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with aortic aneurysm and patients with PAOD and Controls will be investigated in the following manner: Duplexsonography with assessment of the arterial diameters in the aorta and leg arteries. Duplexsonography with assessment of venous reflux in proximal and deep veins of both legs Duplexsonography testing of venous distension in the common femoral vein, the great saphenous vein and the femoral vein.

Study Type

Observational

Enrollment (Actual)

98

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

Non-Probability Sample

Study Population

The population is selected from patients of the angiologic clinic Baselland Bruderholz

Description

Inclusion Criteria:

  • Patients with dilatative arteriopathy (DA) the aortic diameter must be > 3 cm or the popliteal artery diameter > 1.5 cm
  • Patients with arterial occlusive disease (PAOD) defined with an Ankle brachial index (ABI) < 0.9 and positive criteria in the Edinburgh questionnaire
  • Patients able to give informed consent
  • Control group of age matched persons without PAOD (ABI > 0.9) and without DA

Exclusion Criteria:

  • Impossibility to stand
  • Diabetes
  • No given informed consent
  • Persons and patients < 18 years old
  • Acute deep venous thrombosis
  • History of deep venous thrombosis

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Aneurysmatic disease
Patients with dilatative arteriopathy (DA) the aortic diameter must be > 3 cm or the popliteal artery diameter > 1.5 cm
Peripheral arterial occlusive disease
Patients with arterial occlusive disease (PAOD) defined with an Ankle brachial index (ABI) < 0.9 and positive criteria in the Edinburgh questionnaire.
Healthy
Control group of age matched persons without PAOD (ABI > 0.9) and without DA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Venous distension of > 27% in patients with aneurysmatic arterial disease
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Kantonsspital Baselland Bruderholz

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, 2016

Primary Completion (Actual)

March 28, 2017

Study Completion (Actual)

March 28, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00375

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.

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