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

Healthy Volunteers Clinical Trial

— SEQUOIA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545410
• Other study ID #: APHP211541
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: November 2024

Study information

• Verified date: August 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Raluca PAIS, MD
• Phone: +33(0)1.42.16.55.45
• Email: raluca.pais[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• MRI calibration
Non-injected thoracic aorta MRI calibration

Locations

Country	Name	City	State
France	Hôpital de la Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parametric measurement of thoracic aorta values of normal subjects	Thoracic aorta values measured by MRI	24 months
Secondary	Quantitative fibrosis within the aortic wall (%)		24 months
Secondary	Quantitative fat within the aortic wall (%)		24 months
Secondary	Quantitative periaortic fat (g and g/m², when indexed to BSA)		24 months
Secondary	ROC metrics will be used to compare the various sequences (%)		24 months
Secondary	Quantitative flow values within the different aortic segments and the main branches (mL)		24 months
Secondary	Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers		24 months
Secondary	Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)		24 months
Secondary	Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)		24 months