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

NCT ID: NCT05545410

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-11-30

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

healthy volunteers

Group Type: OTHER

MRI calibration

Intervention Type: OTHER

Non-injected thoracic aorta MRI calibration

Interventions

MRI calibration

Non-injected thoracic aorta MRI calibration

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raluca PAIS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital de la Pitié Salpêtrière

Paris, , France

Countries

France

Central Contacts

Raluca PAIS, MD

Role: CONTACT

raluca.pais@aphp.fr

+33(0)1.42.16.55.45

Nadjia KACHENOURA, PhD

Role: CONTACT

nadjia.kachenoura@inserm.fr

01.44.27.91.16

Facility Contacts

Zohra ABBOU, Msc

Role: primary

zohra.abbou@aphp.fr

Khaoula BOUAZIZI, PhD

Role: backup

k.bouazizi@ihuican.org

Other Identifiers

APHP211541

Identifier Type: -

Identifier Source: org_study_id