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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05545410
Acronym
SEQUOIA
Enrollment
60
Registered
2022-09-19
Start date
2022-10-31
Completion date
2024-11-30
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

thoracic aorta, MRI, acquisition calibration, biomarkers

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.

Interventions

OTHERMRI calibration

Non-injected thoracic aorta MRI calibration

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parametric measurement of thoracic aorta values of normal subjects24 monthsThoracic aorta values measured by MRI

Secondary

MeasureTime frame
Quantitative fat within the aortic wall (%)24 months
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
Quantitative fibrosis within the aortic wall (%)24 months
Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers24 months
Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)24 months
Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)24 months
Quantitative flow values within the different aortic segments and the main branches (mL)24 months

Countries

France

Contacts

Primary ContactRaluca PAIS, MD
raluca.pais@aphp.fr+33(0)1.42.16.55.45
Backup ContactNadjia KACHENOURA, PhD
nadjia.kachenoura@inserm.fr01.44.27.91.16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026