LANDMARC Study: a Study With Focus on Aorta Ascendens

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).

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 Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm; Aortic Diseases; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Dilatation; Aortic Elongation
• Intervention / Treatment: Other: 4D-flow MR & CT-scan

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Sophie ML van de Walle, PhD student; Phone Number: +31643904530; Email: sophie.vande.walle@mumc.nl
• Study Contact Backup: Name: Elham Bidar, MD, PhD; Email: elham.bidar@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • MaastrichtUMC
      • Contact: Sophie ML van de Walle, PhD student; Phone Number: +31643904530; Email: sophie.vande.walle@mumc.nl
      • Contact: Elham Bidar, MD, PhD; Email: elham.bidar@mumc.nl
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population of the LANDMARC study will consist of patients who underwent open heart surgery and have participated in FIBAA-bank.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2022
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): January 15, 2025

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Other Study ID Numbers: NL82141.068.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No