NCT02867501

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

August 11, 2016

Last Update Submit

March 31, 2017

Conditions

Keywords

venous distensionvenous reflux

Outcome Measures

Primary Outcomes (1)

  • Venous distension of > 27% in patients with aneurysmatic arterial disease

    one year

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1002/bjs.5630.

    PMID: 17262753BACKGROUND
  • Jeanneret C, Jager 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. doi: 10.1016/j.ejvs.2007.03.018. Epub 2007 May 24.

    PMID: 17524680BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalPopliteal Artery AneurysmPeripheral Arterial Occlusive Disease 1Vascular DiseasesAortic DiseasesVaricose Veins

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
intern

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

May 1, 2016

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03