Venous Distension in Patients With Aneurysmatic Arterial Disease

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867501
• Other study ID #: 2016-00375
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: March 31, 2017
• Start date: May 2016
• Est. completion date: March 28, 2017

Study information

• Verified date: March 2017
• Source: Kantonsspital Baselland Bruderholz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Popliteal Artery Aneurysm
• Varicose Veins
• Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Baselland Bruderholz

References & Publications (2)

Jeanneret C, Baldi T, Hailemariam S, Koella C, Gewaltig J, Biedermann BC. Selective loss of extracellular matrix proteins is linked to biophysical properties of varicose veins assessed by ultrasonography. Br J Surg. 2007 Apr;94(4):449-56. — View Citation

Jeanneret C, Jäger KA, Zaugg CE, Hoffmann U. Venous reflux and venous distensibility in varicose and healthy veins. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):236-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous distension of > 27% in patients with aneurysmatic arterial disease		one year