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Evaluating the Free-Running Framework for Cardiac Function

This study is looking at a new way to do cardiac MRI (magnetic resonance imaging) called the Free-Running Framework (FRF). Cardiac MRI is a safe way to get detailed pictures of your heart without using radiation. The FRF method aims to make cardiac MRI simpler and faster by not requiring you to hold your breath multiple times or use small electrodes (ECG) to monitor your heartbeat during the scan. Researchers want to see if the heart measurements from this new FRF method are similar to those from the standard cardiac MRI. You might be able to join if you have a heart condition and are already scheduled for a cardiac MRI on a 1.5T scanner. The main goal is to compare the left ventricular ejection fraction (LVEF), which is a measure of how well your heart pumps blood, between the FRF and standard MRI during your scheduled scan. The study is currently observational, meaning researchers are just watching and collecting information, and the enrollment status is unclear.

Study design
This is an observational study planning to enroll 300 participants. It is not specified if it's randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Baseline (during study MRI acquisition), so long-term follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07613398

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

Not Yet Recruiting
Not specifiedAll AgesObservational
Matthias Stuber
~300 participants
Updated 2026-05-29 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
mean paired difference (bias) in left ventricular ejection fraction (LVEF) between 5D FISS-FRF and conventional 2D cine CMR
Measured over Baseline (during study MRI acquisition)

Conditions

Congenital Heart Diseases
Cardiac Diseases

Explore related trials

Heart Disorder

Where it's being run

20 sites across 19 states
North Rhine-Westphalia2
California1
Georgia1
Illinois1
Massachusetts1
Minnesota1
Missouri1
Ohio1

Study leadership

  • Matthias Stuber, PhD · PRINCIPAL_INVESTIGATOR · CHUV
  • Tim Leiner, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Kim-Lien Nguyen, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Katerina Eyre, PhD
[email protected]
+41213147513
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • mean paired difference (bias) in left ventricular ejection fraction (LVEF) between 5D FISS-FRF and conventional 2D cine CMRBaseline (during study MRI acquisition)

    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.