LANDMARC Study: a Study With Focus on Aorta Ascendens

Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05655767
• Other study ID #: NL82141.068.22
• Status: Not yet recruiting
• Start date: December 15, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: November 2022
• Source: Maastricht University Medical Center
• Contact: Sophie ML van de Walle, PhD student
• Phone: +31643904530
• Email: sophie.vande.walle[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: January 15, 2025
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years and older

• Able to understand the trial and provide informed consent

• Patients who have participated in the FIBAA-bank

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Dilatation
• Aortic Diseases
• Aortic Dissection

Intervention

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).

Locations

Country	Name	City	State
Netherlands	MaastrichtUMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Until 12 months postoperative
Secondary	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.	Until 12 months postoperative