Clinical trial NCT05655767: LANDMARC Study: a Study With Focus on Aorta Ascendens
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Diseases
Aortic Aneurysm
Aortic Dissection
Aortic Aneurysm, Thoracic
Aortic Dilatation
Aortic Elongation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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)

Primary outcomes:
measure: Indication of the association between WSS (peak WSS and WSS gradient) (through 4D-flow MR and CT) and aortic strain.
timeFrame: Until 12 months postoperative
Secondary outcomes:
measure: Indication of the association between (hemo)dynamic processes within the body (aortic elongation/aortic strain) and (patho-)physiological changes (degree of cardiovascular tissue fibrosis).
timeFrame: Until 12 months postoperative
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Limburg
Study officials:
References: