Abdominal Aortic AneurysmNCT03138434
Advanced MRI in AAA
An observational study of Abdominal Aortic Aneurysm, run by Ron Balm at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2017to 29 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.
Who may be able to join
- Adult patients (≥ 18 years of age)
- Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm
Who cannot join
- Contra-indications for MRI
- Severely reduced renal function (eGFR < 30)
- Previous allergic reaction to intravenous contrast agents
- Suprarenal AAA
- Pararenal AAA
- Previous aneurysm repair
Show all 10Show fewer
- Inflammatory aneurysm
- Mycotic or other infectious aneurysm
- Vasculitis
- Connective tissue disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, 4D flow MRI, DCE-MRI, T1 and T2 mapping
- Medical subject headings
- Aortic Aneurysm, Abdominal
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Wall shear stress (WSS)
Primary outcome of 4D flow MRI
Measured: Time of MRI scan
Kinetic transport constant (Ktrans)
Primary outcome of DCE-MRI
Measured: Time of MRI scan
T1 relaxation time
Primary outcome of T1 mapping
Measured: Time of MRI scan
T2 relaxation time
Primary outcome of T2 mapping
Measured: Time of MRI scan
Secondary outcomes (11)
Peak flow velocity inside the aneurysm
Secondary outcome of 4D flow MRI
Measured: Time of MRI scan
Location of peak wall shear stress
Secondary outcome of 4D flow MRI
Measured: Time of MRI scan
Flow velocity at aneurysm entrance
Secondary outcome of 4D flow MRI
Measured: Time of MRI scan
Flow patterns
Secondary outcome of 4D flow MRI
Measured: Time of MRI scan
Oscillatory shear index
Secondary outcome of 4D flow MRI
Measured: Time of MRI scan
Reverse reflux rate constant (kep)
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Area under the curve of contrast uptake
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Peak enhancement ratio
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Wash-in slope
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Time to peak (TTP)
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Mean transit time (MTT)
Secondary outcome of DCE-MRI
Measured: Time of MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start12 Apr 2017
- Primary completion29 May 2019
- Study completion29 May 2019
Why it stopped: Sufficient acquisitions for DCE-MRI and 4D flow, but not for T1/T2-mapping due to lack of ILT in some participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ron Balm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ron Balm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Ron Balm, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138434
- Sponsor's protocol ID
- NL56823.018.16
- Status last verified
- Jul 2019
- First submitted
- 1 May 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI in AAA
- ClinicalTrials.gov ID
- NCT03138434
- Acronym / sponsor ID
- NL56823.018.16
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, 4D flow MRI, DCE-MRI, T1 and T2 mapping
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient acquisitions for DCE-MRI and 4D flow, but not for T1/T2-mapping due to lack of ILT in some participants.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ron BalmUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 3 May 2017 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an abdominal aortic aneurysms who are patients at the department of vascular surgery of the Academic Medical Center.
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years of age)
- Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm
Key exclusion criteria (10 listed)
- Contra-indications for MRI
- Severely reduced renal function (eGFR < 30)
- Previous allergic reaction to intravenous contrast agents
- Suprarenal AAA
- Pararenal AAA
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
Wall shear stress (WSS)
Time frame: Time of MRI scan
Primary outcome of 4D flow MRI
Kinetic transport constant (Ktrans)
Time frame: Time of MRI scan
Primary outcome of DCE-MRI
T1 relaxation time
Time frame: Time of MRI scan
Primary outcome of T1 mapping
T2 relaxation time
Time frame: Time of MRI scan
Primary outcome of T2 mapping
11 secondary outcomes
Peak flow velocity inside the aneurysm
Time frame: Time of MRI scan
Location of peak wall shear stress
Time frame: Time of MRI scan
Flow velocity at aneurysm entrance
Time frame: Time of MRI scan
Flow patterns
Time frame: Time of MRI scan
Oscillatory shear index
Time frame: Time of MRI scan
Reverse reflux rate constant (kep)
Time frame: Time of MRI scan
Area under the curve of contrast uptake
Time frame: Time of MRI scan
Peak enhancement ratio
Time frame: Time of MRI scan
Wash-in slope
Time frame: Time of MRI scan
Time to peak (TTP)
Time frame: Time of MRI scan
Mean transit time (MTT)
Time frame: Time of MRI scan
Results and safety
The study was stopped early (reason given: Sufficient acquisitions for DCE-MRI and 4D flow, but not for T1/T2-mapping due to lack of ILT in some participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
RecruitingObservational study
Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm
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.
Ron Balm, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Ron Balm at 1 site in Netherlands.
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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Sufficient acquisitions for DCE-MRI and 4D flow, but not for T1/T2-mapping due to lack of ILT in some participants.). Results are not available in the source record.
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?
Wall shear stress (WSS) (time frame: Time of MRI scan). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.