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NCT05655767
LANDMARC Study: a Study With Focus on Aorta Ascendens
Conditions: Aortic Diseases, Aortic Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Dilatation, Aortic Elongation
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 65
Sponsor: Maastricht University Medical Center
Location: Netherlands
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.
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).
Eligibility Criteria
Inclusion Criteria:18 years and olderAble to understand the trial and provide informed consentPatients who have participated in the FIBAA-bankExclusion Criteria:Patients with abnormal congenital cardiothoracic anatomy, with exception of presence of a bicuspid aortic valvePatients with history of chemotherapy, or radiotherapy within thoracic regionPatients with an age >80 yearsPatients with a weight >120 kgPatients with a contra-indication for MRI according to the MUMC+ ODIN protocol nr.
004952Patients with impaired renal function (GFR <30)
Source: ClinicalTrials.gov (NCT05655767). StuddyBuddy aggregates publicly available trial information.