Deep Learning Super-Resolution Single-Beat CMR (DL-SB-CMR)

June 20, 2025 updated by: Alexander Isaak, University Hospital, Bonn

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

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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

107

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

    • NRW
      • Bonn, NRW, Germany, 53123
        • University Hospital Bonn

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with clinical indication for CMR

Description

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

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
Patient cohort
  • suspected myocardial disease with clinical indication for CMR
  • undergoing one CMR with two integrated protocols (standard and DL single beat protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
May - December 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
May - December 2024

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alexander Isaak, PD Dr., University Hospital Bonn, Germany
  • Study Director: Julian Luetkens, Prof., University Hospital Bonn, Germany

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)

May 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

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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