NCT05877755

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Apr 2025Mar 2030

First Submitted

Initial submission to the registry

April 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

5 years

First QC Date

April 5, 2023

Last Update Submit

April 16, 2025

Conditions

Cardiac Disease

Keywords

Cardiac MRISequencesHigh-resolutionMulti-contrastImaging

Outcome Measures

Primary Outcomes (1)

  • Imaging integration success

    Measure of image quality according to signal-to-noise ratio

    60 months

Secondary Outcomes (5)

  • 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)

    60 months

  • Cardiac MRI feature: location and size of myocardial scars/fibrosis

    60 months

  • Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)

    60 months

  • CMR feature extracellular volume fraction (ECV)

    60 months

  • CMR feature ejection fraction

    60 months

Study Arms (1)

Cardiac MRI acquisition

OTHER

200 patients with a clinical indication for cardiac magnetic resonance imaging

Device: Cardiac MRI acquisition

Interventions

Cardiac MRI acquisitionDEVICE

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.

Cardiac MRI acquisition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Pessac, 33600, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36638777BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • BUSTIN Aurelien, PHD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BUSTIN Aurelien, PHD

CONTACT

+33 6 16 29 05 91aurelien.bustin@ihu-liryc.fr

COCHET Hubert, MD, PHD

CONTACT

+33 5 57 65 65 42hubert.cochet@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 26, 2023

Study Start

April 15, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

FR(1)