Aortic DiseasesNCT05655767
LANDMARC Study: a Study With Focus on Aorta Ascendens
An observational study of Aortic Diseases and Aortic Aneurysm, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Aortic diameter is currently used as a gold standard in international guidelines for prediction of aorta pathology (aortic aneurysm and aortic dissection). However, aortic diameter has proven to be insufficiently accurate for making decisions about well-timed preventive interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Diseases, Aortic Aneurysm, Aortic Dissection
- What is being tested?
- 4D-flow MR & CT-scan
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2022to 15 Jan 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population of the LANDMARC study will consist of patients who underwent open heart surgery and have participated in FIBAA-bank.
Who may be able to join
- 18 years and older
- Able to understand the trial and provide informed consent
- Patients who have participated in the FIBAA-bank
Who cannot join
- Patients with abnormal congenital cardiothoracic anatomy, with exception of presence of a bicuspid aortic valve
- Patients with history of chemotherapy, or radiotherapy within thoracic region
- Patients with an age >80 years
- Patients with a weight >120 kg
- Patients with a contra-indication for MRI according to the MUMC+ ODIN protocol nr. 004952
- Patients with impaired renal function (GFR <30)
Trial locations and contacts
1 site in 1 country.
Elham Bidar, MD, PhD contact
Netherlands1 site
MaastrichtUMC
Maastricht, Limburg, 6229 HX
Sophie ML van de Walle, PhD student, +31643904530, sophie.vande.walle@mumc.nl
Elham Bidar, MD, PhD, elham.bidar@mumc.nl
About this study
Official title: Assessment of the pathophysioLogical bAsis of Local Tissue compliaNce Using augmenteD iMAging Techniques to Identify Regional Flow dynamiCs (LANDMARC): a Study With Focus on Aorta Ascendens
Rationale:
Aortic diameter is currently used as a gold standard in international guidelines for prediction of aorta pathology (aortic aneurysm and aortic dissection). However, aortic diameter has proven to be insufficiently accurate for making decisions about well-timed preventive interventions. The LANDMARC study will take place in line with the FIBAA-bank ('Correlatie tussen cardiovasculaire FIBroseringsgraad en Aorta elongatie, dilatatie en Atria dilatatie (FIBAA-bank): een biobank \& databank onderzoek met focus op aorta en atria' (METC-number 2022-3164)), and aims to reveal the undiscovered relationship between WSS (wall shear stress) values and aortic strain. In combination with data from the FIBAA-bank, the LANDMARC study will provide more accurate information for future risk stratification models for cardiovascular pathology (with focus on aortic disease).
Read more
Objectives:
Primary objective: indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.
Secondary objective: indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).
- Conditions
- Aortic Diseases, Aortic Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Dilatation, Aortic Elongation
- Being tested
- 4D-flow MR & CT-scan
- Medical subject headings
- Aortic Diseases, Aortic Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D-flow MR & CT-scanOther
4D-flow MR and CT-scan after cardiac surgery (until 12 months afterwards), for the purpose of obtaining more precise data on (hemo)dynamic processes within the cardiovascular system, in combination with data extraction from the established biobank and databank (FIBAA-bank).
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.
Previous research described the importance of aortic strain for the prediction of aortic disease. By linking this information to information that can be obtained via advanced imaging techniques, future predictions about aortic disease can be made more easily and will be more accurate.
Measured: Until 12 months postoperative
Secondary outcomes (1)
Indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).
During the FIBAA bank, residual tissue (e.g. aorta and atrial tissue) and blood (25ml) were collected, which were then analysed by the Biochemistry department. From these materials, data on for example elasticity and compliance was collected using different staining techniques (elastin-collagen ratio, type I-type II collagen ratio, degree of collagen fibre crosslinking, etc.). This available data is used during the LANDMARC study to indicate associations between degree of cardiovascular tissue fibrosis and aortic elongation/aortic strain.
These associations will demonstrate that cardiovascular tissue response and cell interaction based on dynamic body processes and hemodynamics are important factors for the development of cardiovascular disease.
Measured: Until 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies 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
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655767
- Sponsor's protocol ID
- NL82141.068.22
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the pathophysioLogical bAsis of Local Tissue compliaNce Using augmenteD iMAging Techniques to Identify Regional Flow dynamiCs (LANDMARC): a Study With Focus on Aorta Ascendens
- ClinicalTrials.gov ID
- NCT05655767
- Acronym / sponsor ID
- NL82141.068.22
- Conditions
- Aortic Diseases, Aortic Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Dilatation, Aortic Elongation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 19 Dec 2022 (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.
Rationale:
Aortic diameter is currently used as a gold standard in international guidelines for prediction of aorta pathology (aortic aneurysm and aortic dissection). However, aortic diameter has proven to be insufficiently accurate for making decisions about well-timed preventive interventions. The LANDMARC study will take place in line with the FIBAA-bank ('Correlatie tussen cardiovasculaire FIBroseringsgraad en Aorta elongatie, dilatatie en Atria dilatatie (FIBAA-bank): een biobank \& databank onderzoek met focus op aorta en atria' (METC-number 2022-3164)), and aims to reveal the undiscovered relationship between WSS (wall shear stress) values and aortic strain. In combination with data from the FIBAA-bank, the LANDMARC study will provide more accurate information for future risk stratification models for cardiovascular pathology (with focus on aortic disease).
Objectives:
Primary objective: indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.
Secondary objective: indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population of the LANDMARC study will consist of patients who underwent open heart surgery and have participated in FIBAA-bank.
Key inclusion criteria (3 listed)
- 18 years and older
- Able to understand the trial and provide informed consent
- Patients who have participated in the FIBAA-bank
Key exclusion criteria (6 listed)
- Patients with abnormal congenital cardiothoracic anatomy, with exception of presence of a bicuspid aortic valve
- Patients with history of chemotherapy, or radiotherapy within thoracic region
- Patients with an age >80 years
- Patients with a weight >120 kg
- Patients with a contra-indication for MRI according to the MUMC+ ODIN protocol nr. 004952
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 |
|---|---|---|
| 4D-flow MR & CT-scan4D-flow MR and CT-scan after cardiac surgery (until 12 months afterwards), for the purpose of obtaining more precise data on (hemo)dynamic processes within the cardiovascular system, in combination with data extraction from the established biobank and databank (FIBAA-bank). | Other | – |
Primary outcome
Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.
Time frame: Until 12 months postoperative
Previous research described the importance of aortic strain for the prediction of aortic disease. By linking this information to information that can be obtained via advanced imaging techniques, future predictions about aortic disease can be made more easily and will be more accurate.
1 secondary outcome
Indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).
Time frame: Until 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Elham Bidar, MD, PhD contact
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 Aortic Diseases and Aortic Aneurysm, run by Maastricht University Medical Center 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie ML van de Walle, PhD student (+31643904530, sophie.vande.walle@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain. (time frame: Until 12 months postoperative). 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 19 Dec 2022.