FAST ScanNCT07395843
Clinical Feasibility of Full Free-Breathing Cardiac Magnetic Resonance Imaging
An observational study of FAST Scan, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
To evaluate the feasibility, efficiency, and diagnostic concordance of a full comprehensive free-breathing cardiac magnetic resonance protocol with motion correction and sensing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- FAST Scan
- What is being tested?
- Free-breathing CMR
- How many people
- 605 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to 20 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: any patients with various cardiac diseases referred for clinically indicated contrast-enhanced CMR
Who may be able to join
- consecutive enrollment of patients referred for clinically indicated contrast-enhanced CMR
Who cannot join
- patients with CMR contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- FAST Scan
- Being tested
- Free-breathing CMR
- Keywords
- free-breathing, CMR, compressed sensing, motion correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free-breathing CMRDiagnostic test
scan patients under free-breathing status
| Study group | Role | What they receive |
|---|---|---|
| cine validation | compare free-breathing and breath-holding cine sequences Receives: Diagnostic Test: Free-breathing CMR | |
| T1 mapping and LGE validation | compare free-breathing and breath-holding T1 mapping and LGE sequences Receives: Diagnostic Test: Free-breathing CMR | |
| head-to-head validation | head-to-head comparisons of all sequences between two acquisitions Receives: Diagnostic Test: Free-breathing CMR | |
| full free-breathing CMR | pure full free-breathing cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
scan time
total CMR examination time from the scanning time of first image to the last image
Measured: Measurements are performed within 7 days after the completion of the CMR scan.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Measurements are performed within 7 days after the completion of the CMR scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start12 Nov 2024
- Primary completion31 May 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FAST ScanStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 605 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395843
- Sponsor's protocol ID
- FB-CMR
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Free-Breathing Cardiac Magnetic Resonance Imaging: Clinical Feasibility, Efficiency, and Diagnostic Concordance
- ClinicalTrials.gov ID
- NCT07395843
- Acronym / sponsor ID
- FB-CMR
- Conditions
- FAST Scan
- Keywords
- free-breathing, CMR, compressed sensing, motion correction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility, efficiency, and diagnostic concordance of a full comprehensive free-breathing cardiac magnetic resonance protocol with motion correction and sensing.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cine validation | – | Diagnostic Test: Free-breathing CMRcompare free-breathing and breath-holding cine sequences |
| T1 mapping and LGE validation | – | Diagnostic Test: Free-breathing CMRcompare free-breathing and breath-holding T1 mapping and LGE sequences |
| head-to-head validation | – | Diagnostic Test: Free-breathing CMRhead-to-head comparisons of all sequences between two acquisitions |
| full free-breathing CMR | – | –pure full free-breathing cohort |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any patients with various cardiac diseases referred for clinically indicated contrast-enhanced CMR
Key inclusion criteria (1 listed)
- consecutive enrollment of patients referred for clinically indicated contrast-enhanced CMR
Key exclusion criteria (1 listed)
- patients with CMR contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free-breathing CMRscan patients under free-breathing status | Diagnostic test | T1 mapping and LGE validation, cine validation, head-to-head validation |
Primary outcome
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
3 secondary outcomes
image quality
Time frame: 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.
consistence of native T1 values
Time frame: Measurements are performed within 7 days after the completion of the CMR scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FAST Scan, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scan time (time frame: Measurements are performed within 7 days after the completion of the CMR scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.