LANDMARC Study: a Study With Focus on Aorta Ascendens

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05655767
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 25
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Dilatation; Aortic Elongation	Other: 4D-flow MR & CT-scan

Study Design

• Study Type: Observational
• Anticipated Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Anticipated Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Dec 15, 2023
• Anticipated Study Completion Date: Jan 15, 2025

Outcome Measures

Primary Outcome Measures

1. Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain. [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.

Secondary Outcome Measures

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). [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MaastrichtUMC	Maastricht	Limburg	Netherlands	6229 HX

Sponsors and Collaborators

• Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT05655767
• Other Study ID Numbers: NL82141.068.22
• First Posted: Dec 19, 2022
• Last Update Posted: Dec 19, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aneurysm, Dissecting; Aortic Diseases; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Dec 19, 2022