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Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging (CARDIO-IRM)

Primary Purpose

Cardiac Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac MRI acquisition
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Disease focused on measuring Cardiac MRI, Sequences, High-resolution, Multi-contrast, Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult patient (over 18 years of age) requiring an MRI scan as part of their care. Male or female. Affiliated or beneficiary of a social security scheme Having given his/her oral no objection after having read the information note Exclusion Criteria: Patient unable to give oral consent (guardianship, non-French speaker, etc.) Patient deprived of liberty Patient who does not meet the specific eligibility criteria for an MRI examination: pregnant women, known pathology that may interfere with acquisition (e.g. Parkinson's disease), absolute or relative contraindication to an MRI examination Patient participating in a therapeutic interventional trial or in a period of relative exclusion in relation to another protocol

Sites / Locations

  • Chu de Bordeaux

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiac MRI acquisition

Arm Description

200 patients with a clinical indication for cardiac magnetic resonance imaging

Outcomes

Primary Outcome Measures

Imaging integration success
Measure of image quality according to signal-to-noise ratio

Secondary Outcome Measures

Integration of the collected images in an internal database to develop new reconstruction and image processing algorithms specific to this application (e.g. using artificial intelligence)
Measure of training time and training loss function
Cardiac MRI feature: location and size of myocardial scars/fibrosis
Measured in mL on late gadolinium enhancement images
Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)
Measured in milliseconds
CMR feature extracellular volume fraction (ECV)
Measured in mL/m2
CMR feature ejection fraction
Measured in percentage

Full Information

First Posted
April 5, 2023
Last Updated
May 23, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Grant Agreement ERC SMHEART
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1. Study Identification

Unique Protocol Identification Number
NCT05877755
Brief Title
Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging
Acronym
CARDIO-IRM
Official Title
Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging (CARDIO IRM)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Grant Agreement ERC SMHEART

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of CARDIO-IRM is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology.
Detailed Description
Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of this project is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology. This aim will be achieved by (i) creating a novel imaging technology that collects CMR data in a single continuous free-breathing scan, taking into account post-processing requirements at the very origin of CMR sequence design; (ii) exploiting the unique contrasts generated by this technology to automatically extract quantitative markers on cardiac anatomy, function, and tissue characteristics; and (iii) translating this transformative technology to a clinical setting. This will be the first-ever integrated cardiac imaging pipeline in which CMR images are acquired in a single click, jointly represented in a single volume, and automatically analysed. This will unlock obstacles for broader acceptance of CMR and unleash the full potential of CMR to maximize its impact on patient trajectories. The results of this project will pave the way towards robust image-based strategies for personalized patient care (diagnosis, risk stratification, therapy selection, monitoring, and image-guided interventions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Cardiac MRI, Sequences, High-resolution, Multi-contrast, Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac MRI acquisition
Arm Type
Other
Arm Description
200 patients with a clinical indication for cardiac magnetic resonance imaging
Intervention Type
Device
Intervention Name(s)
Cardiac MRI acquisition
Intervention Description
All patients will have additional images collected during the magnetic resonance imaging (MRI) examination. These are high-resolution multi-contrast cardiac MRI sequences in gradient echo or in balanced steady state free precession with synchronization on the electrocardiogram. The acquisitions last between 1 minute and 10 minutes. This duration depends on the patient's heart rate and breathing rate. The imaging protocol will last approximately 50 minutes. MRI examinations will be performed on a 1.5 Tesla clinical system with specific cardiac imaging coils.
Primary Outcome Measure Information:
Title
Imaging integration success
Description
Measure of image quality according to signal-to-noise ratio
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Integration of the collected images in an internal database to develop new reconstruction and image processing algorithms specific to this application (e.g. using artificial intelligence)
Description
Measure of training time and training loss function
Time Frame
60 months
Title
Cardiac MRI feature: location and size of myocardial scars/fibrosis
Description
Measured in mL on late gadolinium enhancement images
Time Frame
60 months
Title
Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)
Description
Measured in milliseconds
Time Frame
60 months
Title
CMR feature extracellular volume fraction (ECV)
Description
Measured in mL/m2
Time Frame
60 months
Title
CMR feature ejection fraction
Description
Measured in percentage
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patient (over 18 years of age) requiring an MRI scan as part of their care. Male or female. Affiliated or beneficiary of a social security scheme Having given his/her oral no objection after having read the information note Exclusion Criteria: Patient unable to give oral consent (guardianship, non-French speaker, etc.) Patient deprived of liberty Patient who does not meet the specific eligibility criteria for an MRI examination: pregnant women, known pathology that may interfere with acquisition (e.g. Parkinson's disease), absolute or relative contraindication to an MRI examination Patient participating in a therapeutic interventional trial or in a period of relative exclusion in relation to another protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BUSTIN Aurelien, PHD
Phone
+33 6 16 29 05 91
Email
aurelien.bustin@ihu-liryc.fr
First Name & Middle Initial & Last Name or Official Title & Degree
COCHET Hubert, MD, PHD
Phone
+33 5 57 65 65 42
Email
hubert.cochet@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BUSTIN Aurelien, PHD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BUSTIN Aurelien, PHD
Phone
+33 6 16 29 05 91
Email
aurelien.bustin@ihu-liryc.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
36638777
Citation
Bustin A, Stuber M, Sermesant M, Cochet H. Smart cardiac magnetic resonance delivering one-click and comprehensive assessment of cardiovascular disease. Eur Heart J. 2023 Feb 21;44(8):636-637. doi: 10.1093/eurheartj/ehac814. No abstract available.
Results Reference
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Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging

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