Advanced MRI in AAA

July 2, 2019 updated by: Ron Balm

This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA.

Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.

It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.

Study Overview

Status

Terminated

Conditions

Detailed Description

This prospective study evaluates the feasibility, reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm (AAA).

The MRI sequences and their primary outcomes are:

  • Four-dimensional (4D) flow MRI and wall shear stress (WSS)
  • Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)
  • T1 and T2 mapping (T1 and T2 relaxation times)

Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. Reproducibility is tested by calculating interscan, intra- and interobserver variability. Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Department of Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years of age)
  • Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm

Exclusion Criteria:

  • Contra-indications for MRI
  • Severely reduced renal function (eGFR < 30)
  • Previous allergic reaction to intravenous contrast agents
  • Suprarenal AAA
  • Pararenal AAA
  • Previous aneurysm repair
  • Inflammatory aneurysm
  • Mycotic or other infectious aneurysm
  • Vasculitis
  • Connective tissue disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Optimization phase
The first five patients will be included for the optimization of the MRI sequences. This is to ensure that a standard protocol will work for different sizes of AAA. These patients will only be scanned once.
Study phase

This phase will commence after the optimization phase. This phase is where we want to assess the feasibility, reproducibility and association with disease severity between MRI parameters and AAA.

These twenty patients will be scanned twice, with an interval of 1 week ± 5 days.

The study will be completed when we have 20 patients with 2 scans for each sequence, or when a maximum number of 30 patients in the study phase have been scanned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wall shear stress (WSS)
Time Frame: Time of MRI scan
Primary outcome of 4D flow MRI
Time of MRI scan
Kinetic transport constant (Ktrans)
Time Frame: Time of MRI scan
Primary outcome of DCE-MRI
Time of MRI scan
T1 relaxation time
Time Frame: Time of MRI scan
Primary outcome of T1 mapping
Time of MRI scan
T2 relaxation time
Time Frame: Time of MRI scan
Primary outcome of T2 mapping
Time of MRI scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak flow velocity inside the aneurysm
Time Frame: Time of MRI scan
Secondary outcome of 4D flow MRI
Time of MRI scan
Location of peak wall shear stress
Time Frame: Time of MRI scan
Secondary outcome of 4D flow MRI
Time of MRI scan
Flow velocity at aneurysm entrance
Time Frame: Time of MRI scan
Secondary outcome of 4D flow MRI
Time of MRI scan
Flow patterns
Time Frame: Time of MRI scan
Secondary outcome of 4D flow MRI
Time of MRI scan
Oscillatory shear index
Time Frame: Time of MRI scan
Secondary outcome of 4D flow MRI
Time of MRI scan
Reverse reflux rate constant (kep)
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan
Area under the curve of contrast uptake
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan
Peak enhancement ratio
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan
Wash-in slope
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan
Time to peak (TTP)
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan
Mean transit time (MTT)
Time Frame: Time of MRI scan
Secondary outcome of DCE-MRI
Time of MRI scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ron Balm

Investigators

  • Principal Investigator: Ron Balm, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2017

Primary Completion (Actual)

May 29, 2019

Study Completion (Actual)

May 29, 2019

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL56823.018.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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