We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LANDMARC Study: a Study With Focus on Aorta Ascendens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05655767
Recruitment Status : Not yet recruiting
First Posted : December 19, 2022
Last Update Posted : December 19, 2022
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Aortic Diseases Aortic Aneurysm Aortic Dissection Aortic Aneurysm, Thoracic Aortic Dilatation Aortic Elongation Other: 4D-flow MR & CT-scan

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : December 15, 2022
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : January 15, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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).

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain. [ Time Frame: 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). [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05655767


Contacts
Layout table for location contacts
Contact: Sophie ML van de Walle, PhD student +31643904530 sophie.vande.walle@mumc.nl
Contact: Elham Bidar, MD, PhD elham.bidar@mumc.nl

Locations
Layout table for location information
Netherlands
MaastrichtUMC
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Sophie ML van de Walle, PhD student    +31643904530    sophie.vande.walle@mumc.nl   
Contact: Elham Bidar, MD, PhD       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         
Sponsors and Collaborators
Maastricht University Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT05655767    
Other Study ID Numbers: NL82141.068.22
First Posted: December 19, 2022    Key Record Dates
Last Update Posted: December 19, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aneurysm, Dissecting
Aortic Diseases
 Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases