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Multimodal mAgnetic Resonance imaGIng in Cardiovascular Disease (MAGIC)

Multimodal-MRI in Cardiovascular Diseases

This single-center, prospective, observational cohort study aims to evaluate the clinical application value of multi-modal cardiovascular magnetic resonance (CMR) imaging in patients with cardiovascular diseases (CVD).

While traditional imaging methods have limitations in fully evaluating myocardial tissue characteristics, multi-modal CMR offers a comprehensive, non-invasive "one-stop" assessment. It can simultaneously evaluate heart structure, function, tissue features (such as fibrosis and edema), and hemodynamics.

The study plans to enroll patients with suspected or confirmed CVD. Participants will undergo a comprehensive multi-modal CMR scan (including Cine, T1/T2 mapping, Late Gadolinium Enhancement, and 4D flow sequences) as part of their evaluation. In addition to clinical evaluation, the study will explore sequence optimization (e.g., comparing pre-contrast vs. post-contrast Cine, and 3-slice vs. 9-slice T1 mapping) and evaluate deep learning-based virtual native enhancement (VNE) models trained under different sequence protocols.

By tracking clinical outcomes, the study seeks to establish a standardized imaging assessment system to improve the early detection, accurate diagnosis, risk stratification, and prognostic prediction for various types of cardiovascular diseases.

Aperçu de l'étude

Description détaillée

Cardiovascular disease (CVD) remains a leading cause of global mortality and disability. Accurate and early assessment of cardiac structure, function, and myocardial tissue characteristics is crucial for optimal clinical management. Cardiac Magnetic Resonance (CMR) has evolved from single morphological imaging into advanced multi-modal imaging. By integrating Cine, Late Gadolinium Enhancement (LGE), T1/T2 mapping, and 4D flow techniques, multi-modal CMR serves as a "gold standard" that provides a comprehensive macroscopic and cellular-level evaluation, including the identification of myocardial fibrosis, edema, and complex hemodynamic alterations.

Despite its clinical potential, systematic research comparing the diagnostic efficacy and prognostic value of multi-modal CMR features across a broad spectrum of cardiovascular diseases (such as ischemic heart disease, non-ischemic cardiomyopathy, and valvular diseases) is still lacking. Furthermore, optimization of scan efficiency, standardization of sequence acquisition protocols, and the development of contrast-free or AI-driven virtual imaging techniques (such as deep learning-based virtual native enhancement ) represent critical avenues to enhance clinical utility.

This prospective, observational registry study is designed to address this gap by establishing a large-scale, standardized CMR imaging database. Approximately 2,000 patients with clinically suspected or confirmed CVD will be consecutively enrolled. Following routine clinical care pathways, participants will undergo a "one-stop" multi-modal CMR examination using 3.0T MRI scanners.

To refine imaging protocols and validate novel synthetic imaging algorithms, a subset/sub-cohort analysis will specifically investigate the impacts of acquisition parameters-comparing performance between pre-contrast Cine vs. post-contrast Cine, as well as 3-slice vs. 9-slice T1 mapping protocols-on downstream machine learning/deep learning models for virtual native enhancement and tissue characterization.

The primary objectives are to: 1) systematically delineate the imaging feature spectrum across different CVD subtypes; 2) optimize multi-modal CMR acquisition protocols and validate deep learning models for virtual image generation (e.g., VNE); 3) assess the sensitivity of hemodynamic and tissue-characterization parameters (especially T1 mapping and extracellular volume [ECV]) in detecting early cardiac damage; and 4) explore the correlation between multi-modal CMR parameters and major adverse cardiovascular events (MACE) during the follow-up period. Ultimately, this study aims to provide robust, evidence-based support for precision diagnosis and risk stratification in cardiovascular medicine.

Type d'étude

Observationnel

Inscription (Estimé)

2000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: jiaqi Fan
  • Numéro de téléphone: +86 15267029492
  • E-mail: jqfan@zju.edu.cn

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310009
        • Recrutement
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population consists of consecutive adult patients (aged 18 years and older) who are clinically suspected or confirmed to have cardiovascular diseases (CVD), including but not limited to ischemic heart disease, non-ischemic cardiomyopathy, myocarditis, and valvular heart disease. These participants are enrolled from the Second Affiliated Hospital Zhejiang University School of Medicine. They are patients who are scheduled to undergo a multi-modal cardiac magnetic resonance (CMR) examination as part of their clinical evaluation to determine disease etiology or assess myocardial tissue characteristics.

La description

Inclusion Criteria:

  • Aged 18 years and older, with no gender restrictions.

Clinically suspected or confirmed cardiovascular disease (including but not limited to ischemic heart disease, non-ischemic cardiomyopathy, myocarditis, valvular disease, etc.), requiring a cardiac magnetic resonance (CMR) examination to determine the etiology or evaluate myocardial tissue characteristics.

No contraindications to magnetic resonance examination, and able to cooperate with breath-holding instructions.

Voluntarily participate in this study and sign a written informed consent form.

Exclusion Criteria:

  • Absolute contraindications: Implantation of non-MRI compatible metallic foreign bodies (e.g., old pacemakers, implantable cardioverter-defibrillators [ICD], aneurysm clips, etc.).

Relative contraindications: Severe claustrophobia, unable to complete the examination despite communication.

Severe renal insufficiency.

Special populations: Pregnant or lactating women.

Presence of severe arrhythmias (e.g., persistent atrial fibrillation) leading to severely impaired magnetic resonance signal acquisition, rendering the image quality inadequate for diagnosis.

Poor expected compliance: Unable to complete follow-up, or deemed unsuitable for enrollment by the investigator for other reasons.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)
Délai: Baseline (at the time of CMR scan)
The Area Under the Receiver Operating Characteristic Curve (AUC) will be calculated to assess the diagnostic performance of multi-modal CMR parameters (specifically T1 mapping and extracellular volume [ECV]) in differentiating various types of cardiovascular diseases (e.g., ischemic vs. non-ischemic). The final clinical diagnosis based on ESC/ACC guidelines will serve as the gold standard.
Baseline (at the time of CMR scan)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation Between Imaging Parameters and Clinical Indicators
Délai: Baseline
To evaluate the Pearson or Spearman correlation coefficients between multi-modal CMR parameters (such as LGE, T1/T2 mapping, 4D flow metrics) and clinical functional/laboratory indicators.
Baseline
Incidence of Major Adverse Cardiovascular Events (MACE)
Délai: Up to 3 years
To evaluate the occurrence rate of MACE during the follow-up period. MACE is defined as a composite of cardiac death, readmission for heart failure, malignant arrhythmia (sustained ventricular tachycardia/ventricular fibrillation), and non-fatal myocardial infarction.
Up to 3 years
Model performance for virtual native enhancement across different sequence acquisition protocols
Délai: At baseline
Model performance for virtual LGE generation across sequence protocols: Structural Similarity Index Measure (SSIM)
At baseline
Model performance for virtual LGE generation across sequence protocols: Peak Signal-to-Noise Ratio (PSNR)
Délai: At baseline
Peak Signal-to-Noise Ratio (PSNR) will be evaluated to compare virtual LGE algorithms trained on pre- vs. post-contrast Cine and 3-slice vs. 9-slice T1 mapping protocols.
At baseline
Model performance for virtual LGE generation across sequence protocols: DICE coefficient
Délai: At baseline
DICE coefficient will be evaluated to compare virtual LGE algorithms trained on pre- vs. post-contrast Cine and 3-slice vs. 9-slice T1 mapping protocols.
At baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

26 mai 2026

Première soumission répondant aux critères de contrôle qualité

26 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The individual participant data (IPD) will not be shared because of current institutional policies and national data security regulations regarding the protection of patient privacy and human genetic resources. The data contains sensitive medical imaging information that is restricted from being transferred or shared outside the participating institution without specific governmental and ethical approvals.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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