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

Starting soon

Conditions studied: Congenital Heart Diseases, Cardiac Diseases

In brief

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.

Key facts

Study ID

NCT07613398

Run by

Matthias Stuber

People needed

300

Starts

2026-06-01

Expected to finish

2030-09-01

Last updated by the study team

2026-05-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston's Children Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Ohio State University — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University of Melbourne — Melbourne, Victoria, Australia
• Fundacion Cardioinfantil-LaCardio — Bogotá, Capital District, Colombia
• University of Bonn — Bonn, North Rhine-Westphalia, Germany
• Cologne University Medical Center — Cologne, North Rhine-Westphalia, Germany
• Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany
• Università Cattolica - Fondazione Policlinico Gemelli IRCCS — Rome, Lazio, Italy
• Mie University — Tsu, Mie-ken, Japan
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands
• National University of Singapore — Singapore, Singapore, Singapore
• University of Cape Town — Cape Town, Western Cape, South Africa
• King's College London — London, London, United Kingdom

Full record on ClinicalTrials.gov

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