Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Other: MRI calibration

• Registration Number: NCT05545410
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Study Start: 2022-10
• Primary Completion: 2024-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy volunteers	MRI calibration	-

Primary Outcome Measures

Name	Time	Method
Parametric measurement of thoracic aorta values of normal subjects	24 months	Thoracic aorta values measured by MRI

Secondary Outcome Measures

Name	Time	Method
Quantitative periaortic fat (g and g/m², when indexed to BSA)	24 months
ROC metrics will be used to compare the various sequences (%)	24 months
Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)	24 months
Quantitative fibrosis within the aortic wall (%)	24 months
Quantitative flow values within the different aortic segments and the main branches (mL)	24 months
Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers	24 months
Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)	24 months
Quantitative fat within the aortic wall (%)	24 months

Trial Locations

Locations (1)

Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France