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. 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.

Study Overview

Detailed Description

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.

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. The investigators will systematically collect baseline imaging parameters and perform long-term clinical follow-up.

The primary objectives are to: 1) systematically delineate the imaging feature spectrum across different CVD subtypes; 2) assess the sensitivity of hemodynamic and tissue-characterization parameters (especially T1 mapping and extracellular volume [ECV]) in detecting early cardiac damage; and 3) 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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

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

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.

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Imaging Parameters and Clinical Indicators
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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