An International Multicenter, Multivendor Evaluation of the Free-Running Framework for Cardiac Function

NCT07613398 | Not Yet Recruiting

• 1 other identifier: 2025-00923
• Study Type: observational
• Target: 300
• Locations: 10 countries
• Sites: 20

Brief Summary

This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring cardiac images. The investigators want to verify whether this method can provide functional heart measurements comparable to those obtained with traditional methods. More specifically, the goal of the study is to compare the measurements obtained with FRF to those obtained with standard sequences, to ensure they match and that this new approach can be reliably used in clinical practice. The FRF technique works differently from standard cardiac MRI. In standard exams, patients are asked to hold their breath several times and small electrodes (ECG) are used to monitor the heartbeat during the scan. These steps are needed to get clearer images of the heart as it moves. With FRF, these steps are no longer necessary: the scan is performed while patients' breath normally and without ECG monitoring. In addition, standard MRI takes multiple 2D slices of the heart, one after another. The FRF method instead captures a 3D image of the entire heart in one go, which can improve the consistency of the exam and reduce errors when doctors analyze the images later. This is all possible because the FRF method records data continuously and then organizes the images afterward based on how participants heart and breathing were moving during the exam. This helps the imager to get clear images of the heart, even without breath-holding or ECG monitoring. This project is aimed at individuals with heart disease who require cardiac MRI exams to monitor their health status (age ≥ 18 years) and are able to clearly understand the instructions provided by the research team. The investigators have already conducted small-scale technical and feasibility studies using FRF. These studies have shown that FRF is easy to use, faster than traditional methods, and provides image quality comparable to standard imaging techniques. The investigators now wish to evaluate its use in a clinical setting. More specifically, the investigators need to verify that FRF provides the same essential diagnostic information as standard techniques, so that it can be reliably used in future patient care. A maximum of 300 participants will be included in the investigation of this MRI technique between 2026 and 2031. This is a multi-center study, conducted internationally across 18 centers. This project is being carried out in compliance with Swiss legislation. The investigators follow all internationally recognized guidelines. The competent ethics committee has reviewed and approved this project.

Conditions

Congenital Heart Diseases; Cardiac Diseases

Keywords

Free-running; Cine magnetic resonance imaging; Ventricular function; Multicenter; Multivendor; FISS (Fast- Interrupted Steady-State); Compressed sensing; Pragmatic clinical study

Outcome Measures

Primary Outcomes (1)

• mean paired difference (bias) in left ventricular ejection fraction (LVEF) between 5D FISS-FRF and conventional 2D cine CMR

  estimated with a two-sided 95% confidence interval within each pre-defined patient cohort. The study is designed to ensure that the half-width of this confidence interval does not exceed 1.25% LVEF per cohort.

  Baseline (during study MRI acquisition)

Secondary Outcomes (20)

• Scan Efficiency

  Baseline (during study MRI acquisition)

• Quantitative Image Quality

  Baseline (during study MRI acquisition)

• Qualitative Image Quality

  Baseline (during study MRI acquisition)

• Failure Rate

  Baseline (during study MRI acquisition)

• Anatomical Coverage

  Baseline (during study MRI acquisition)

Study Arms (3)

Patients with congenital heart disease

FAST-CMR will evaluate the technique's performance in complex, heterogeneous anatomy.

Patients unable to perform breath-holding

including those with advanced heart failure, pulmonary hypertension, or chronic obstructive pulmonary disease (COPD), representing a subgroup where conventional breath-held CMR techniques are often suboptimal or not feasible.

Other cardiovascular disease patients who are able to perform breath-holding

This group represents the standard patient population for whom conventional CMR is currently optimized.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will prospectively include 300 patients (\~15-20 per site) with known or suspected cardiac disease who are referred for a clinically indicated CMR scan as part of their routine clinical work-up.

You may qualify if:

• Diagnosed with cardiac disease of any complexity and scheduled for a clinical cardiac MRI on a clinical 1.5T MRI scanner
• Able to understand and provide written informed consent or, for minors, ability to provide assent with written consent from a parent/legal representative, per local law and site policy prior to the study
• Ability to undergo MRI without contraindications
• Agrees to be informed in the event of incidental findings

You may not qualify if:

• Severe claustrophobia preventing MRI completion
• Presence of non-MRI compatible implants (e.g., pacemakers, certain metallic implants)
• Contraindications to the intravenous contrast agent
• Movement disorders or inability to remain still during the scan

Sponsors & Collaborators

• Matthias Stuber: lead
• Mayo Clinic: collaborator
• University of California, Los Angeles: collaborator

Study Sites (20)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Boston's Children Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Fundacion Cardioinfantil-LaCardio

Bogotá, Capital District, 111156, Colombia

Location

University of Bonn

Bonn, North Rhine-Westphalia, 53113, Germany

Location

Cologne University Medical Center

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Università Cattolica - Fondazione Policlinico Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Mie University

Tsu, Mie-ken, 514-8507, Japan

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

National University of Singapore

Singapore, Singapore, 119275, Singapore

Location

University of Cape Town

Cape Town, Western Cape, 7700, South Africa

Location

King's College London

London, London, WC2R2LS, United Kingdom

Location

Related Publications (5)

• Ogier AC, Baup S, Ilanjian G, Touray A, Rocca A, Banus J, Monton Quesada I, Nicoletti M, Ledoux JB, Richiardi J, Holtackers RJ, Yerly J, Stuber M, Hullin R, Rotzinger D, van Heeswijk RB. Cardiac function assessment with deep-learning-based automatic segmentation of free-running four-dimensional whole-heart cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2025 Dec 24;28(1):102677. doi: 10.1016/j.jocmr.2025.102677. Online ahead of print.

  PMID: 41453741 BACKGROUND

• Koktzoglou I, Edelman RR. Radial fast interrupted steady-state (FISS) magnetic resonance imaging. Magn Reson Med. 2018 Apr;79(4):2077-2086. doi: 10.1002/mrm.26881. Epub 2017 Aug 30.

  PMID: 28856788 BACKGROUND

• Yerly J, Roy CW, Milani B, Eyre K, Raifee MJ, Stuber M. High on sparsity: Interbin compensation of cardiac motion for improved assessment of left-ventricular function using 5D whole-heart MRI. Magn Reson Med. 2025 Mar;93(3):975-992. doi: 10.1002/mrm.30323. Epub 2024 Oct 9.

  PMID: 39385350 BACKGROUND

• Bastiaansen JAM, Piccini D, Di Sopra L, Roy CW, Heerfordt J, Edelman RR, Koktzoglou I, Yerly J, Stuber M. Natively fat-suppressed 5D whole-heart MRI with a radial free-running fast-interrupted steady-state (FISS) sequence at 1.5T and 3T. Magn Reson Med. 2020 Jan;83(1):45-55. doi: 10.1002/mrm.27942. Epub 2019 Aug 27.

  PMID: 31452244 BACKGROUND

• Di Sopra L, Piccini D, Coppo S, Stuber M, Yerly J. An automated approach to fully self-gated free-running cardiac and respiratory motion-resolved 5D whole-heart MRI. Magn Reson Med. 2019 Dec;82(6):2118-2132. doi: 10.1002/mrm.27898. Epub 2019 Jul 18.

  PMID: 31321816 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthias Stuber, PhD

  CHUV

  PRINCIPAL INVESTIGATOR

• Tim Leiner, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Kim-Lien Nguyen, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Eyre, PhD

CONTACT

+41213147513; katerina.eyre@chuv.ch

Matthias Stuber, PhD

CONTACT

+41213147534; matthias.stuber@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Section Head CIBM MRI CHUV-UNIL

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 29, 2026

Record last verified: 2026-04

Locations

GB (1); ZA (1); IT (1); DE (3); NL (1); US (9); JP (1); SG (1); AU (1); CO (1)