Clinical trial NCT05545410: Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers
Official title: Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: thoracic aorta
MRI
acquisition calibration
biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.

Detailed description: This Magnetic Resonance imaging study of the thoracic aorta aims to: 1- enhance patient comfort during the examination, shorten appointment waiting times and overall reduce MRI cost, and 2- provide a reliable diagnosis and risk assessment of aorta-related diseases occurring in hypertension, obesity or diabetes but also throughout normal aging.

The impact of MRI acquisition innovations on the measurement of biomarkers that are extracted from image post-processing software and therein on disease characterization (normal values, severity thresholds, etc.) must be systematically reevaluated. More specifically, the investigators design image acquisition and automated image processing methods to reduce operator variability. This study will optimize thoracic aortic MRI acquisition sequences for the quantification of diagnostic-assisting biomarkers in a healthy population.

Eligibility criteria: Inclusion Criteria:

* Subject aged between 20 and 35 or between 50 and 70 (limits included)
* BMI \< 30 kg/m²
* Asymptomatic subject
* Having given informed, free and written consent
* Affiliated to a French social security scheme or entitled

Exclusion Criteria:

* Contraindication to MRI (claustrophobia, presence of a metallic foreign body)
* Pregnant or breastfeeding woman
* Known cardiac pathology
* Personal cardiovascular history
* Person deprived of liberty by court decision or benefiting from legal protection (under guardianship or curatorship)
* Abuse of alcohol or narcotics
* Subject under AME
* Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person

Primary outcomes:
measure: Parametric measurement of thoracic aorta values of normal subjects
timeFrame: 24 months
Secondary outcomes:
measure: Quantitative fibrosis within the aortic wall (%)
timeFrame: 24 months
measure: Quantitative fat within the aortic wall (%)
timeFrame: 24 months
measure: Quantitative periaortic fat (g and g/m², when indexed to BSA)
timeFrame: 24 months
measure: ROC metrics will be used to compare the various sequences (%)
timeFrame: 24 months
measure: Quantitative flow values within the different aortic segments and the main branches (mL)
timeFrame: 24 months
measure: Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers
timeFrame: 24 months
measure: Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)
timeFrame: 24 months
measure: Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Raluca PAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: