Clinical Feasibility of Full Free-Breathing Cardiac Magnetic Resonance Imaging

January 31, 2026 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
605

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
scan time
Time Frame: Measurements are performed within 7 days after the completion of the CMR scan.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
image quality
Time Frame: Measurements are performed within 7 days after the completion of the CMR scan.
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
Time Frame: Measurements are performed within 7 days after the completion of the CMR scan.
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
Time Frame: Measurements are performed within 7 days after the completion of the CMR scan.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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