LANDMARC Study: a Study With Focus on Aorta Ascendens
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|ClinicalTrials.gov Identifier: NCT05655767|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2022
Last Update Posted : December 19, 2022
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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).
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).
|Condition or disease||Intervention/treatment|
|Aortic Diseases Aortic Aneurysm Aortic Dissection Aortic Aneurysm, Thoracic Aortic Dilatation Aortic Elongation||Other: 4D-flow MR & CT-scan|
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|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|
|Estimated Study Start Date :||December 15, 2022|
|Estimated Primary Completion Date :||December 15, 2023|
|Estimated Study Completion Date :||January 15, 2025|
- Other: 4D-flow MR & CT-scan
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).
- 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.
- 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 ]
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.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 18 years and older
- Able to understand the trial and provide informed consent
- Patients who have participated in the FIBAA-bank
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05655767
|Contact: Sophie ML van de Walle, PhD firstname.lastname@example.org|
|Contact: Elham Bidar, MD, PhDemail@example.com|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Contact: Sophie ML van de Walle, PhD student +31643904530 firstname.lastname@example.org|
|Contact: Elham Bidar, MD, PhD email@example.com|
|Sub-Investigator: Elham Bidar, MD, PhD|
|Sub-Investigator: Casper Mihl, MD, PhD|
|Principal Investigator: Jos G Maessen, MD, PhD, Prof|
|Principal Investigator: Joachim E Wildberger, MD, PhD, Prof|
|Responsible Party:||Maastricht University Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 19, 2022 Key Record Dates|
|Last Update Posted:||December 19, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Aortic Aneurysm, Thoracic