Aortic Aneurysm, AbdominalNCT02867501
Venous Distension in Patients With Aneurysmatic Arterial Disease
An observational study of Aortic Aneurysm, Abdominal and Popliteal Artery Aneurysm, run by Kantonsspital Baselland Bruderholz.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm, Peripheral Arterial Occlusive Disease
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 28 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population is selected from patients of the angiologic clinic Baselland Bruderholz
Who may be able to join
- 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
Who cannot join
- Impossibility to stand
- Diabetes
- No given informed consent
- Persons and patients < 18 years old
- Acute deep venous thrombosis
- History of deep venous thrombosis
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm, Peripheral Arterial Occlusive Disease, Vascular Diseases, Aortic Diseases, Varicose Veins
- Keywords
- venous distension, venous reflux
- Medical subject headings
- Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm, Peripheral Arterial Occlusive Disease 1, Vascular Diseases, Aortic Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Venous distension of > 27% in patients with aneurysmatic arterial disease
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janis Christian Bartelt, Kantonsspital Baselland Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867501
- Sponsor's protocol ID
- 2016-00375
- Other IDs
- 2016
- Status last verified
- Mar 2017
- First submitted
- 11 Aug 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17262753Jeanneret 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.
PubMed 17524680
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Distension in Patients With Aneurysmatic Arterial Disease Compared to the Venous Distension in Patients With Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT02867501
- Acronym / sponsor ID
- 2016-00375
- Conditions
- Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm, Peripheral Arterial Occlusive Disease, Vascular Diseases, Aortic Diseases, Varicose Veins
- Keywords
- venous distension, venous reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population is selected from patients of the angiologic clinic Baselland Bruderholz
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Impossibility to stand
- Diabetes
- No given informed consent
- Persons and patients < 18 years old
- Acute deep venous thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous distension of > 27% in patients with aneurysmatic arterial disease
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 17262753Jeanneret 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.
- Background: PubMed 17524680Jeanneret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Popliteal Artery Aneurysm, run by Kantonsspital Baselland Bruderholz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous distension of > 27% in patients with aneurysmatic arterial disease (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867501, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.