Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers
SEQUOIA
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Oct 2022
Typical duration for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 19, 2022
August 1, 2022
1.9 years
August 3, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parametric measurement of thoracic aorta values of normal subjects
Thoracic aorta values measured by MRI
24 months
Secondary Outcomes (8)
Quantitative fibrosis within the aortic wall (%)
24 months
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 flow values within the different aortic segments and the main branches (mL)
24 months
- +3 more secondary outcomes
Study Arms (1)
healthy volunteers
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Pitié Salpêtrière
Paris, 75013, France
Study Officials
- PRINCIPAL INVESTIGATOR
Raluca PAIS, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2022
First Posted
September 19, 2022
Study Start
October 1, 2022
Primary Completion
September 1, 2024
Study Completion
November 1, 2024
Last Updated
September 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.