Validation of Free-Breathing Cardiac Cine: A single-center prospective study

Prospective Observational Study on Free-Breathing Cardiac Cine MRI Using a Deep Learning Super-Resolution Engine - PRECISE-DL Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058653

Enrollment

Registered

2025-07-31

Start date

2026-11-30

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients requiring cardiac MRI due to ischemic heart disease, cardiomyopathy, valvular heart disease, congenital heart disease, etc.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients clinically indicated for cardiac MRI. 2. Age 18 years or older and under 90 years. 3. Subjects who have provided written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to MRI. 2. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs). 3. Pregnant or potentially pregnant women.

Design outcomes

Primary

Measure	Time frame
Difference in left ventricular ejection fraction (LVEF) obtained by conventional breath-hold cardiac cine MRI versus free-breathing cardiac cine MRI.	—

Secondary

Measure	Time frame
1. Differences in cardiac volumetric and functional parameters - Left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular cardiac output, left ventricular myocardial mass, right ventricular end-diastolic volume (RVEDV), right ventricular end-systolic volume (RVESV), right ventricular cardiac output, left atrial maximum volume, left atrial minimum volume, right atrial maximum volume, and right atrial minimum volume obtained by conventional breath-hold versus free-breathing cine MRI. 2. Differences in myocardial deformation metrics - Myocardial strain and strain rate measured with conventional breath-hold versus free-breathing cine MRI. 3. Difference in qualitative image quality - Difference in the proportion of cine images rated as Grade 3 or higher on qualitative image quality scoring between the two methods. 4. Differences in quantitative image quality metrics - Difference in quantitative measures of image quality (e.g., signal-to-noise ratio, contrast-to-noise ratio) between conventional breath-hold and free-breathing cine MRI. 5. Difference in acquisition time - Difference in total cine image acquisition time between the two techniques. 6. Interobserver agreement - Interobserver agreement (e.g., Cohen's kappa) for qualitative image quality grading. 7. Subgroup analysis of the primary outcome - Analysis of the primary outcome (difference in LVEF) in patient subgroups stratified by age, sex, body mass index (BMI), respiratory rate, heart rate, and presence/absence of arrhythmia.	—

Measure

Time frame

1. Differences in cardiac volumetric and functional parameters - Left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular cardiac output, left ventricular myocardial mass, right ventricular end-diastolic volume (RVEDV), right ventricular end-systolic volume (RVESV), right ventricular cardiac output, left atrial maximum volume, left atrial minimum volume, right atrial maximum volume, and right atrial minimum volume obtained by conventional breath-hold versus free-breathing cine MRI. 2. Differences in myocardial deformation metrics - Myocardial strain and strain rate measured with conventional breath-hold versus free-breathing cine MRI. 3. Difference in qualitative image quality - Difference in the proportion of cine images rated as Grade 3 or higher on qualitative image quality scoring between the two methods. 4. Differences in quantitative image quality metrics - Difference in quantitative measures of image quality (e.g., signal-to-noise ratio, contrast-to-noise ratio) between conventional breath-hold and free-breathing cine MRI. 5. Difference in acquisition time - Difference in total cine image acquisition time between the two techniques. 6. Interobserver agreement - Interobserver agreement (e.g., Cohen's kappa) for qualitative image quality grading. 7. Subgroup analysis of the primary outcome - Analysis of the primary outcome (difference in LVEF) in patient subgroups stratified by age, sex, body mass index (BMI), respiratory rate, heart rate, and presence/absence of arrhythmia.

—

Countries

Japan

Contacts

Public ContactHidenobu Takagi

Tohoku University Graduate School of Medicine Advanced Radiological Imaging Collaborative Research

hidenobu.takagi.b8@tohoku.ac.jp0227177312

Outcome results