Aortic Valve DiseaseNCT02467062
Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
A study testing MRI in people with Aortic Valve Disease and Aortic Aneurysm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Valve Disease, Aortic Aneurysm
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patients with aortic aneurysm and/or aortic valve disease older than 18 years.
Who cannot join
- Patients <18 years
- Pregnancy.
- Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.
Read the detailed description
Currently, the timing of the replacement of the ascending aorta is solely based on the aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm. Several publictions have shown that the flow profile and wall sheer stress derived from 4D flow MRI are significantly different between the valve morphology, the type of the aneurysm (tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases, especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic. Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and settings would be optimised for 4D flow MRI and the contrast will not be given.
Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease, post-operative patients and patients under surveillance for known aortic root and/or aortic valve disease will be imaged. Only patients having a clinical indication for an MRI of the aorta/aortic valve will be included.
- Conditions
- Aortic Valve Disease, Aortic Aneurysm
- Being tested
- MRI
- Keywords
- 4D flow
- Medical subject headings
- Aortic Valve Disease, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI measurement to evualuate for 4D blood flow pattern
| Study group | Role | What they receive |
|---|---|---|
| 4Dflow MRI parallel imaging | Active comparator | 4D flow MRI with conventional parallel imaging Receives: Device: MRI |
| 4D flow ktARC parallel imaging | Other | 4D flow MRI kt ARC spatiotemporal parallel imaging Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the bloodflow pattern
Measured: 1 day
Secondary outcomes (1)
wall sheer stress
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Kaoru Tanaka, MD PhD, Principal investigator, Department of Radiology, Universitair Ziekenhuis BrusselJan Nijs, MD, Principal investigator, Brussels Center for Aortic and Cardiovascular Connective Tissue Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467062
- Sponsor's protocol ID
- 4D AORTIC FLOW MRI
- Status last verified
- Dec 2016
- First submitted
- 2 Jun 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
- ClinicalTrials.gov ID
- NCT02467062
- Acronym / sponsor ID
- 4D AORTIC FLOW MRI
- Conditions
- Aortic Valve Disease, Aortic Aneurysm
- Keywords
- 4D flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Jun 2015 (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 investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.
Detailed description
Currently, the timing of the replacement of the ascending aorta is solely based on the aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm. Several publictions have shown that the flow profile and wall sheer stress derived from 4D flow MRI are significantly different between the valve morphology, the type of the aneurysm (tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases, especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic. Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and settings would be optimised for 4D flow MRI and the contrast will not be given.
Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease, post-operative patients and patients under surveillance for known aortic root and/or aortic valve disease will be imaged. Only patients having a clinical indication for an MRI of the aorta/aortic valve will be included.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4Dflow MRI parallel imaging | Active comparator | Device: MRI4D flow MRI with conventional parallel imaging |
| 4D flow ktARC parallel imaging | Other | Device: MRI4D flow MRI kt ARC spatiotemporal parallel imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with aortic aneurysm and/or aortic valve disease older than 18 years.
Key exclusion criteria (3 listed)
- Patients <18 years
- Pregnancy.
- Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI measurement to evualuate for 4D blood flow pattern | Device | 4D flow ktARC parallel imaging, 4Dflow MRI parallel imaging |
Primary outcome
the bloodflow pattern
Time frame: 1 day
1 secondary outcome
wall sheer stress
Time frame: 1 day
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 6 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Active, not recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
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.
Kaoru Tanaka, MD PhD principal investigator
Department of Radiology, Universitair Ziekenhuis Brussel
Jan Nijs, MD principal investigator
Brussels Center for Aortic and Cardiovascular Connective Tissue Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Aortic Valve Disease and Aortic Aneurysm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 1 inclusion and 3 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 6 Dec 2016. 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 Belgium. 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 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?
the bloodflow pattern (time frame: 1 day). 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 6 Dec 2016.