Clinical Feasibility of Full Free-Breathing Cardiac Magnetic Resonance Imaging

Full Free-Breathing Cardiac Magnetic Resonance Imaging: Clinical Feasibility, Efficiency, and Diagnostic Concordance

To evaluate the feasibility, efficiency, and diagnostic concordance of a full comprehensive free-breathing cardiac magnetic resonance protocol with motion correction and sensing.

Study Overview

• Status: Completed
• Conditions: FAST Scan
• Intervention / Treatment: Diagnostic test: Free-breathing CMR

Detailed Description

This study aims to establish a large-scale, clinically oriented full free-breathing cardiac MRI framework to eliminate dependence on patient breath-holding, substantially shorten scan time, and improve patient comfort. Building on prior successful implementation of compressed sensing and motion correction techniques, the invesitgators will collaborate with the MRI vendor and sequence scientists to develop a comprehensive set of free-breathing sequences, including cine imaging, T1/T2 mapping, flow, perfusion, and late gadolinium enhancement (LGE). The study will then prospectively enroll a large, disease-diverse cohort of cardiovascular patients at Fuwai Hospital and systematically compare the full free-breathing protocol with conventional breath-hold protocols in terms of acquisition time, image quality, and agreement of quantitative parameters, thereby providing a comprehensive assessment of technical feasibility and clinical value.

• Study Type: Observational
• Enrollment (Actual): 605

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

any patients with various cardiac diseases referred for clinically indicated contrast-enhanced CMR

Description

Inclusion Criteria:

• consecutive enrollment of patients referred for clinically indicated contrast-enhanced CMR

Exclusion Criteria:

• patients with CMR contraindications

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cine validation; compare free-breathing and breath-holding cine sequences	Diagnostic test: Free-breathing CMR; scan patients under free-breathing status
T1 mapping and LGE validation; compare free-breathing and breath-holding T1 mapping and LGE sequences	Diagnostic test: Free-breathing CMR; scan patients under free-breathing status
head-to-head validation; head-to-head comparisons of all sequences between two acquisitions	Diagnostic test: Free-breathing CMR; scan patients under free-breathing status
full free-breathing CMR; pure full free-breathing cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scan time	total CMR examination time from the scanning time of first image to the last image	Measurements are performed within 7 days after the completion of the CMR scan.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image quality	5-point Likert scale will be applied to assess image quality between two scanning methods, with a score of ≥3 considered clinically acceptable. Image quality was assessed visually using a 5-point Likert scale, defined as follows: 5 = excellent image quality; 4 = good quality with mild motion artifacts or distortion; 3 = presence of motion artifacts or distortion but sufficient image quality; 2 = fair quality with significant motion artifacts or distortion, limiting diagnostic utility; and 1 = non-diagnostic quality.	Measurements are performed within 7 days after the completion of the CMR scan.
consistence of left ventricular ejection fraction	Linear regression and Bland-Altman analyses will be used to assess the correlation and agreement of left ventricular ejection fraction (%) from different techniques.	Measurements are performed within 7 days after the completion of the CMR scan.
consistence of native T1 values	Linear regression and Bland-Altman analyses will be used to assess the correlation and agreement of native T1 values (ms) from different techniques.	Measurements are performed within 7 days after the completion of the CMR scan.

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CMR; free-breathing; compressed sensing; motion correction
• Other Study ID Numbers: FB-CMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No