NCT01104688

Brief Summary

The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic resonance imaging without contrast, this study will look closely at flow, the stresses hereby induced, as well as signs of inflammation in the vessel wall.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

April 14, 2010

Last Update Submit

January 12, 2015

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal Aortic AneurysmWall StressShear StressInflammationMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Left ventricular longitudinal strain for perioperative cardiac monitoring in aortic aneurysm surgery using transthoracic 2-dimensional echocardiography: a a feasibility and repeatability study.feasibility and repeatability study.

    12 Months

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from our clinical database.

You may qualify if:

  • Infrarenal abdominal aorta aneurysm (AAA)

You may not qualify if:

  • Lack of signed, informed consent
  • Pacemaker or other implanted metal prostheses
  • Claustrophobia
  • Dementia
  • Diabetes Mellitus
  • Thoracoabdominal aorta aneurysm, per Crawford/Safi criteria
  • Ehlers-Danlos, Marfans, or other diagnosed connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalInflammation

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob W Budtz-Lilly, MD

    Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Counsultant MD PhD

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 15, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

DK(1)