Advanced MRI in AAA

NCT03138434 | Terminated

• 1 other identifier: NL56823.018.16
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; 4D flow MRI; DCE-MRI; T1 and T2 mapping

Outcome Measures

Primary Outcomes (4)

• Wall shear stress (WSS)

  Primary outcome of 4D flow MRI

  Time of MRI scan

• Kinetic transport constant (Ktrans)

  Primary outcome of DCE-MRI

  Time of MRI scan

• T1 relaxation time

  Primary outcome of T1 mapping

  Time of MRI scan

• T2 relaxation time

  Primary outcome of T2 mapping

  Time of MRI scan

Secondary Outcomes (11)

• Peak flow velocity inside the aneurysm

  Time of MRI scan

• Location of peak wall shear stress

  Time of MRI scan

• Flow velocity at aneurysm entrance

  Time of MRI scan

• Flow patterns

  Time of MRI scan

• Oscillatory shear index

  Time of MRI scan

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ron Balm: lead

Study Sites (1)

Department of Vascular Surgery

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Ron Balm, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: April 12, 2017
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

NL (1)