- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07617844
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: jiaqi Fan
- Número de teléfono: +86 15267029492
- Correo electrónico: jqfan@zju.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: linyun Xie
- Número de teléfono: +86 15990004158
- Correo electrónico: 12518519@zju.edu.cn
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Reclutamiento
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Contacto:
- jiaqi Fan
- Número de teléfono: +86 15267024942
- Correo electrónico: jqfan@zju.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)
Periodo de tiempo: Baseline (at the time of CMR scan)
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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.
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Baseline (at the time of CMR scan)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation Between Imaging Parameters and Clinical Indicators
Periodo de tiempo: Baseline
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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.
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Baseline
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Incidence of Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: Up to 3 years
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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.
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Up to 3 years
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Model performance for virtual native enhancement across different sequence acquisition protocols
Periodo de tiempo: At baseline
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Model performance for virtual LGE generation across sequence protocols: Structural Similarity Index Measure (SSIM)
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At baseline
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Model performance for virtual LGE generation across sequence protocols: Peak Signal-to-Noise Ratio (PSNR)
Periodo de tiempo: At baseline
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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.
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At baseline
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Model performance for virtual LGE generation across sequence protocols: DICE coefficient
Periodo de tiempo: At baseline
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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.
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At baseline
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Paiva L, Ferreira MJ, Afonso S, Donato P, Goncalves L. Cardiac T1 mapping in non-ST-segment elevation myocardial infarction: temporal changes in myocardial fibrosis. Front Cardiovasc Med. 2025 May 23;12:1563368. doi: 10.3389/fcvm.2025.1563368. eCollection 2025.
- Eichhorn C, Greulich S, Bucciarelli-Ducci C, Sznitman R, Kwong RY, Grani C. Multiparametric Cardiovascular Magnetic Resonance Approach in Diagnosing, Monitoring, and Prognostication of Myocarditis. JACC Cardiovasc Imaging. 2022 Jul;15(7):1325-1338. doi: 10.1016/j.jcmg.2021.11.017. Epub 2022 Jan 12.
- Leong DP, Joseph PG, McKee M, Anand SS, Teo KK, Schwalm JD, Yusuf S. Reducing the Global Burden of Cardiovascular Disease, Part 2: Prevention and Treatment of Cardiovascular Disease. Circ Res. 2017 Sep 1;121(6):695-710. doi: 10.1161/CIRCRESAHA.117.311849.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0319
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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