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An International Multicenter, Multivendor Evaluation of the Free-Running Framework for Cardiac Function (FAST-CMR)

2026年5月21日 更新者：Matthias Stuber

Assessment and Validation of the Established Free-Running Framework for Cardiac Function by Magnetic Resonance Imaging (FAST-CMR): An International Multi-Center, Multi-Vendor Study at 1.5T

This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring cardiac images. The investigators want to verify whether this method can provide functional heart measurements comparable to those obtained with traditional methods. More specifically, the goal of the study is to compare the measurements obtained with FRF to those obtained with standard sequences, to ensure they match and that this new approach can be reliably used in clinical practice. The FRF technique works differently from standard cardiac MRI. In standard exams, patients are asked to hold their breath several times and small electrodes (ECG) are used to monitor the heartbeat during the scan. These steps are needed to get clearer images of the heart as it moves. With FRF, these steps are no longer necessary: the scan is performed while patients' breath normally and without ECG monitoring. In addition, standard MRI takes multiple 2D slices of the heart, one after another. The FRF method instead captures a 3D image of the entire heart in one go, which can improve the consistency of the exam and reduce errors when doctors analyze the images later. This is all possible because the FRF method records data continuously and then organizes the images afterward based on how participants heart and breathing were moving during the exam. This helps the imager to get clear images of the heart, even without breath-holding or ECG monitoring. This project is aimed at individuals with heart disease who require cardiac MRI exams to monitor their health status (age ≥ 18 years) and are able to clearly understand the instructions provided by the research team. The investigators have already conducted small-scale technical and feasibility studies using FRF. These studies have shown that FRF is easy to use, faster than traditional methods, and provides image quality comparable to standard imaging techniques. The investigators now wish to evaluate its use in a clinical setting. More specifically, the investigators need to verify that FRF provides the same essential diagnostic information as standard techniques, so that it can be reliably used in future patient care. A maximum of 300 participants will be included in the investigation of this MRI technique between 2026 and 2031. This is a multi-center study, conducted internationally across 18 centers.

This project is being carried out in compliance with Swiss legislation. The investigators follow all internationally recognized guidelines. The competent ethics committee has reviewed and approved this project.

調査の概要

状態

まだ募集していません

条件

詳細な説明

Cardiovascular disease remains the leading cause of death in industrialized nations. While a range of diagnostic tools exists for cardiovascular disease detection and monitoring, magnetic resonance imaging (MRI) remains the only modality that enables a safe, non-invasive assessment of the heart without exposure to ionizing radiation. MRI allows for a comprehensive evaluation of cardiac anatomy, function, myocardial tissue characterization, and blood flow quantification, making it a powerful tool for cardiovascular diagnostics.

Despite strong clinical evidence supporting its utility, cardiac MRI (CMR) remains underutilized, primarily due to the length and complexity of a traditional CMR exam. Several factors contribute to the length and complexity of a standard CMR exam. First, a standard CMR protocol relies heavily on two-dimensional (2D) image acquisitions, each requiring manual slice planning by an experienced technologist-a process that is both time consuming and highly dependent on operator expertise. Second, traditional image acquisition requires electrocardiogram (ECG) triggering to synchronize with the cardiac cycle, requiring additional setup and potentially introducing errors if the ECG signal is suboptimal. Finally, most conventional sequences rely on repeated patient breath-holding to minimize respiratory motion artifacts, which can be particularly challenging for individuals with severe cardiovascular disease, congenital anomalies, or limited compliance. Even for highly skilled personnel, this process is timeconsuming and inefficient. Consequently, a significant portion of the patient's time in the scanner is spent on preparation and planning rather than actual image acquisition, leading to prolonged exam durations and increased healthcare costs.

Given these challenges, there is a strong need for simplified, automated, and time-efficient CMR acquisitions. In response to this challenge, the investigators research group has developed an innovative "free-running framework" (FRF)-a set of MRI methods that continuously acquire threedimensional (3D) image data across the entire cardiac cycle and throughout free breathing, irrespective of cardiac or respiratory motion. Unlike conventional CMR sequences that require separate, prospectively planned acquisitions for each imaging plane and time point, FRF employs continuous, self-navigated data acquisition. This eliminates the need for complex slice planning and enables retrospective reconstruction of cardiac motion, ensuring that imaging is both standardized and independent of user expertise. By leveraging advanced motion-resolved reconstruction algorithms developed by the investigators group, the investigators can derive both cardiac and respiratory motion from a single dataset, providing a fully automated, 3D whole-heart imaging approach.

Once diagnosed, patients with cardiac diseases often require lifelong monitoring and repeated imaging assessments to guide treatment decisions and evaluate disease progression. This makes a non-ionizing imaging modality like CMR admirable. Nonetheless, the prolonged scan durations and intricate manual planning associated with traditional CMR limit its accessibility and practical feasibility. By eliminating the need for slice planning and reducing scan complexity, FRF has the potential to significantly improve imaging for cardiac disease patients by:

  • Standardizing imaging: producing user-independent results robust to anatomical variations.
  • Reducing scan times: without compromising diagnostic information.
  • Improving accessibility: enabling easier adoption in centers with less experienced technologists.

The feasibility of FRF has been demonstrated in experimental, pre-clinical, and small observational clinical studies, with no observed adverse effects. This study aims to evaluate its clinical feasibility and efficiency in real-world cardiac disease patients across multiple cardiac institutions, serving as a precursor for larger validation studies and eventual clinical implementation. This study will provide the first systematic clinical evaluation of 3D FRF across multiple cardiac institutions in cardiac disease patients, assessing both its technical feasibility and potential workflow benefits in a real-world setting. In particular, this study will:

  • Evaluate whether diagnostic information from FRF matches or exceeds standard CMR.
  • Assess the efficiency gains and the impact of automated, self-navigated imaging on scan duration and patient comfort.

If successful, this study will lay the groundwork for future multi-center validation clinical trial studies and eventual clinical integration, addressing a critical gap in CMR accessibility and efficiency.

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095
        • University of California, Los Angeles
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • Emory University
        • コンタクト：
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Ann & Robert H Lurie Children's Hospital of Chicago
        • コンタクト：
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
    • Minnesota
      • Rochester、Minnesota、アメリカ、55902
        • Mayo Clinic
        • コンタクト：
    • Missouri
      • St Louis、Missouri、アメリカ、63130
        • Washington University in St. Louis
        • コンタクト：
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • Ohio State University
        • コンタクト：
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Children's Hospital of Philadelphia
        • コンタクト：
    • Texas
      • Dallas、Texas、アメリカ、75390
  • イギリス
    • London
      • London、London、イギリス、WC2R2LS
        • King's College London
        • コンタクト：
  • イタリア
    • Lazio
      • Rome、Lazio、イタリア、00168
        • Università Cattolica - Fondazione Policlinico Gemelli IRCCS
        • コンタクト：
  • オランダ
    • Limburg
      • Maastricht、Limburg、オランダ、6229 HX
        • Maastricht University Medical Center
        • コンタクト：
  • オーストラリア
    • Victoria
      • Melbourne、Victoria、オーストラリア、3010
        • University of Melbourne
        • コンタクト：
  • コロンビア
    • Capital District
      • Bogotá、Capital District、コロンビア、111156
        • Fundacion Cardioinfantil-LaCardio
        • コンタクト：
  • シンガポール
    • Singapore
      • Singapore、Singapore、シンガポール、119275
        • National University of Singapore
        • コンタクト：
  • ドイツ
    • North Rhine-Westphalia
      • Bonn、North Rhine-Westphalia、ドイツ、53113
        • University of Bonn
        • コンタクト：
      • Cologne、North Rhine-Westphalia、ドイツ、50931
        • Cologne University Medical Center
        • コンタクト：
    • State of Berlin
      • Berlin、State of Berlin、ドイツ、10117
        • Charité - Universitätsmedizin Berlin
        • コンタクト：
  • 南アフリカ
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7700
        • University of Cape Town
        • コンタクト：
  • 日本
    • Mie-ken
      • Tsu、Mie-ken、日本、514-8507
        • Mie University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

This study will prospectively include 300 patients (~15-20 per site) with known or suspected cardiac disease who are referred for a clinically indicated CMR scan as part of their routine clinical work-up.

説明

Inclusion Criteria:

  • Diagnosed with cardiac disease of any complexity and scheduled for a clinical cardiac MRI on a clinical 1.5T MRI scanner
  • Able to understand and provide written informed consent or, for minors, ability to provide assent with written consent from a parent/legal representative, per local law and site policy prior to the study
  • Ability to undergo MRI without contraindications
  • Agrees to be informed in the event of incidental findings

Exclusion Criteria:

  • Severe claustrophobia preventing MRI completion
  • Presence of non-MRI compatible implants (e.g., pacemakers, certain metallic implants)
  • Contraindications to the intravenous contrast agent
  • Movement disorders or inability to remain still during the scan

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
Patients with congenital heart disease
FAST-CMR will evaluate the technique's performance in complex, heterogeneous anatomy.
Patients unable to perform breath-holding
including those with advanced heart failure, pulmonary hypertension, or chronic obstructive pulmonary disease (COPD), representing a subgroup where conventional breath-held CMR techniques are often suboptimal or not feasible.
Other cardiovascular disease patients who are able to perform breath-holding
This group represents the standard patient population for whom conventional CMR is currently optimized.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
mean paired difference (bias) in left ventricular ejection fraction (LVEF) between 5D FISS-FRF and conventional 2D cine CMR
時間枠：Baseline (during study MRI acquisition)
estimated with a two-sided 95% confidence interval within each pre-defined patient cohort. The study is designed to ensure that the half-width of this confidence interval does not exceed 1.25% LVEF per cohort.
Baseline (during study MRI acquisition)

二次結果の測定

結果測定
メジャーの説明
時間枠
Scan Efficiency
時間枠：Baseline (during study MRI acquisition)
  • Sequence acquisition time: scanner-reported acquisition duration for 5D FISS-FRF and conventional 2D cine imaging. This will include the timing of the necessary localizers specific to the imaging plane for each acquisition mode.
  • Workflow time: elapsed time from initiation of cine planning to completion of cine acquisitions, including slice planning, patient instruction, rest between breath-holds, and repeated acquisitions when required.
Baseline (during study MRI acquisition)
Quantitative Image Quality
時間枠：Baseline (during study MRI acquisition)
o Contrast ratio and endocardial-to-blood-pool interface sharpness between 5D FISS-FRF and conventional 2D cine.
Baseline (during study MRI acquisition)
Qualitative Image Quality
時間枠：Baseline (during study MRI acquisition)
o Likert scale (0-4) consensus grading by ≥2 expert CMR readers blinded to images from both techniques.
Baseline (during study MRI acquisition)
Failure Rate
時間枠：Baseline (during study MRI acquisition)
o Percentage of non-diagnostic or excluded scans.
Baseline (during study MRI acquisition)
Anatomical Coverage
時間枠：Baseline (during study MRI acquisition)
o Extent of volumetric coverage of the entire heart and related great vessels.
Baseline (during study MRI acquisition)
Multiparametric Capability
時間枠：Baseline (during study MRI acquisition)
o Presence of additional diagnostic insights from respiratory motion tracking of FRF.
Baseline (during study MRI acquisition)
Clinical Acceptability of LVEF Measurements (±5% Threshold)
時間枠：Baseline (during study MRI acquisition)
o Exploratory analyses will assess whether observed agreement metrics are compatible with commonly used clinical acceptability thresholds (e.g., ±5% LVEF). These analyses are hypothesis-generating and intended to inform future confirmatory studies.
Baseline (during study MRI acquisition)
LV mass
時間枠：Baseline (during study MRI acquisition)
Comparison between 5D FISS-FRF and 2D conventional cine
Baseline (during study MRI acquisition)
Regional wall motion abnormalities
時間枠：Baseline (during study MRI acquisition)
assessed using a 4-point likert scale per AHA segment (normal, hypokinesia, akinesia, dyskinesia)
Baseline (during study MRI acquisition)
Left and right atrial volumes
時間枠：Baseline (during study MRI acquisition)
maximum and minimum volumes and total atrial emptying fraction derived from conventional 2D cine long-axis views compared to 5D FISS-FRF
Baseline (during study MRI acquisition)
Agreement of Automated Ventricular Ejection Fraction Measurements (LVEF, RVEF)
時間枠：Baseline (during study MRI acquisition)
Agreement of automatically post-processed ventricular ejection fraction measurements (LVEF, RVEF) derived from 5D FISS-FRF with (1) standard post-processing of 5D FISS-FRF and (2) standard post-processing of conventional 2D cine cardiac MRI. Agreement will be assessed using appropriate statistical metrics.
Baseline (during study MRI acquisition)
Agreement of Automated Ventricular Function Measurements (LVEDV, LVESV, LVSV, RVEDV, RVESV, RVSV)
時間枠：Baseline (during study MRI acquisition)
Agreement of automatically post-processed ventricular function metrics (LVEDV, LVESV, LVSV, RVEDV, RVESV, RVSV) derived from 5D FISS-FRF with (1) standard post-processing of 5D FISS-FRF and (2) standard post-processing of conventional 2D cine cardiac MRI. Agreement will be assessed using appropriate statistical metrics.
Baseline (during study MRI acquisition)
Feasibility of AI-Based Image Reconstruction
時間枠：Baseline (during study MRI acquisition)
Percentage of reconstructed datasets that are considered clinically usable based on predefined quality criteria.
Baseline (during study MRI acquisition)
Reconstruction Time
時間枠：Baseline (during study MRI acquisition)
Comparison of reconstruction time between AI-based reconstruction and standard compressed sensing methods.
Baseline (during study MRI acquisition)
Accuracy of Ventricular Ejection Fraction Measurements
時間枠：Baseline (during study MRI acquisition)
Comparison of left and right ventricular ejection fraction (LVEF, RVEF) between AI-based and standard reconstructions.
Baseline (during study MRI acquisition)
Accuracy of Ventricular Volume Measurements
時間枠：Baseline (during study MRI acquisition)
Comparison of left and right ventricular end-diastolic volume (EDV), end-systolic volume (ESV), and stroke volume (SV) between AI-based and standard reconstructions.
Baseline (during study MRI acquisition)
Accuracy of Left Ventricular Mass Measurements
時間枠：Baseline (during study MRI acquisition)
Comparison of left ventricular mass between AI-based and standard reconstructions.
Baseline (during study MRI acquisition)
Voxel-wise Image Similarity Between Reconstruction Methods
時間枠：Baseline (during study MRI acquisition)
Image similarity assessed using structural similarity index measure (SSIM), peak signal-to-noise ratio (PSNR), and root mean squared error (RMSE).
Baseline (during study MRI acquisition)
Quantitative Image Quality
時間枠：Baseline (during study MRI acquisition)
Contrast ratio and endocardial-to-blood-pool interface sharpness between reconstruction methods.
Baseline (during study MRI acquisition)
Qualitative Image Quality
時間枠：Baseline (during study MRI acquisition)
Likert scale (0-4) consensus grading by ≥2 expert CMR readers blinded to images from both reconstruction methods.
Baseline (during study MRI acquisition)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Matthias Stuber

協力者

Mayo Clinic
University of California, Los Angeles

捜査官

  • 主任研究者：Matthias Stuber, PhD、CHUV
  • 主任研究者：Tim Leiner, MD, PhD、Mayo Clinic
  • 主任研究者：Kim-Lien Nguyen, MD、University of California, Los Angeles

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2030年9月1日

試験登録日

最初に提出

2026年2月27日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-00923

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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