LANDMARC Study: a Study With Focus on Aorta Ascendens

NCT05655767 | Unknown DMC

• 1 other identifier: NL82141.068.22
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Diseases; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic; Aortic Dilatation; Aortic Elongation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Interventions

4D-flow MR & CT-scan OTHER

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years and older
• Able to understand the trial and provide informed consent
• Patients who have participated in the FIBAA-bank

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Aortic Diseases; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aneurysm; Dissection, Blood Vessel; Acute Aortic Syndrome

Central Study Contacts

Sophie ML van de Walle, PhD student

CONTACT

+31643904530; sophie.vande.walle@mumc.nl

Elham Bidar, MD, PhD

CONTACT

elham.bidar@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 19, 2022
• Study Start: December 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 15, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-11

Locations

NL (1)