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Completed

NCT Number: NCT07029789

Deep Learning Super-Resolution Single-Beat CMR

Deep learning super-resolution reconstruction is an emerging technique that enhances the resolution of cardiac magnetic resonance (CMR) scans beyond the original acquisition through post-processing. This study investigates whether a deep learning-based single-beat super-resolution CMR protocol-including cine, T2-STIR, and LGE sequences-can provide diagnostic equivalence to a standard segmented CMR protocol. Total scan time, diagnostic confidence, and diagnostic interchangeability are compared between protocols, with particular focus on wall motion abnormalities, myocardial edema, pericardial effusion, late gadolinium enhancement and final diagnosis. The goal is to assess diagnostic interchangeability while improving efficiency and motion robustness.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53123, Germany

About this study

Cardiac magnetic resonance (CMR) is the gold standard for non-invasive assessment of myocardial diseases, providing comprehensive information through e.g. cine imaging, T2-weighted sequences, and late gadolinium enhancement (LGE). Conventional CMR protocols typically rely on segmented (multi-shot) acquisitions over multiple heartbeats and require repeated breath-holds, which can limit patient comfort and compliance. While these segmented sequences offer high spatial resolution, they are prone to motion and respiratory artifacts-particularly in patients with arrhythmias or dyspnea-and contribute to long total examination times.

Recent advances in deep learning (DL) reconstruction techniques have enabled substantial acceleration of segmented CMR sequences, particularly for cine and LGE imaging. These approaches effectively reduce acquisition time but still rely on regular cardiac rhythm and adequate breath-holding capacity, limiting their applicability in more challenging patient populations. In contrast, single beat (or: single-shot) imaging acquires data within a single heartbeat, offering a motion-robust alternative, though at the cost of lower spatial resolution.

Efforts to streamline CMR are ongoing, with some studies proposing to reduce comprehensive exam times to 30 minutes or less. In parallel, full DL-based reconstruction MRI protocols are being increasingly explored across MRI domains, including neuroimaging and musculoskeletal imaging. Applying deep learning super-resolution to CMR, particularly in combination with single-beat acquisitions with the option of free-breathing acquisition, may enhance both speed and robustness.

This prospective investigates whether a deep learning-based single-beat super-resolution CMR protocol - including single-shot cine, T2-STIR, and LGE sequences in both short- and long-axis views - can provide diagnostic interchangeability to a standard segmented protocol. All participants undergo both protocols during the same exam session. Total scan times are compared between protocols using Student's t-test. Three blinded readers evaluate predefined diagnostic categories including wall motion abnormalities, pericardial effusion, myocardial edema, LGE, and the final CMR diagnosis. Generalized estimating equations with bootstrapped 95% confidence intervals and a predefined equivalence margin of ±5% was used for the interchangeability analysis. Agreement in categorical ratings was evaluated using Cohen's Kappa and Fleiss' Kappa, as appropriate. Diagnostic confidence was rated on a 5-point Likert scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical indication for CMR
  • Aged 18 years or older.
  • Willing to participate in the study.
  • Able and willing to provide signed informed consent.

Exclusion criteria

  • Pregnant or breastfeeding women
  • Non-removable magnetic metallic implants, prosthetic devices, or extensive tattoos covering large areas of the body
  • Presence of a non-MRI safe pacemaker or neurostimulator

Treatment and study plan

Primary outcomes

  1. Diagnostic interchangeability

    Time frame: May - December 2024

    Assessment of diagnostic interchangeability between the deep learning-based single-beat SuperRes CMR protocol and the standard segmented CMR protocol. Diagnostic categories include wall motion abnormalities, pericardial effusion, myocardial edema, late gadolinium enhancement, and the final CMR diagnosis. Interchangeability was evaluated using generalized estimating equations with bootstrapped 95% confidence intervals and a predefined equivalence margin of ±5%. For each category, the outcome is expressed as an individual equivalence index (%), defined as the difference in agreement probabilities.

Secondary outcomes

  1. Scan time

    Time frame: May - December 2024

    Comparison of total scan duration between the deep learning-based single-beat SuperRes CMR protocol and the standard segmented CMR protocol.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Clinical Evaluation of Deep Learning-Enhanced Super-Resolution Single-Beat CMR: Prospective Comparison Study

Acronym: DL-SB-CMR

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 19, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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