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Venous Distension in Patients With Aneurysmatic Arterial Disease

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ClinicalTrials.gov Identifier: NCT02867501
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Janis Christian Bartelt, Kantonsspital Baselland Bruderholz

Brief Summary:
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.

Condition or disease
Aortic Aneurysm, Abdominal Popliteal Artery Aneurysm Peripheral Arterial Occlusive Disease Vascular Diseases Aortic Diseases Varicose Veins

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.

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Venous Distension in Patients With Aneurysmatic Arterial Disease Compared to the Venous Distension in Patients With Arterial Occlusive Disease
Study Start Date : May 2016
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : March 28, 2017

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.



Primary Outcome Measures :
  1. Venous distension of > 27% in patients with aneurysmatic arterial disease [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population is selected from patients of the angiologic clinic Baselland Bruderholz
Criteria

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

Publications:
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Responsible Party: Janis Christian Bartelt, intern, Kantonsspital Baselland Bruderholz
ClinicalTrials.gov Identifier: NCT02867501     History of Changes
Other Study ID Numbers: 2016-00375
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Janis Christian Bartelt, Kantonsspital Baselland Bruderholz:
venous distension
venous reflux

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Varicose Veins
Arterial Occlusive Diseases
Dilatation, Pathologic
Peripheral Arterial Disease
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases