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Multimodal mAgnetic Resonance imaGIng in Cardiovascular Disease (MAGIC)

26 juli 2026 bijgewerkt door: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

2000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Werving
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation Between Imaging Parameters and Clinical Indicators
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

26 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0319

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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