Multimodal mAgnetic Resonance imaGIng in Cardiovascular Disease

NCT07617844 | Recruiting

• 1 other identifier: 2026-0319
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Ischemic Heart Disease (IHD); Cardiomyopathy; Myocarditis; Heart Valve Diseases

Keywords

Cardiac Magnetic Resonance; Magnetic Resonance Imaging; Multimodal Imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)

  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 Outcomes (5)

• Correlation Between Imaging Parameters and Clinical Indicators

  Baseline

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Up to 3 years

• Model performance for virtual native enhancement across different sequence acquisition protocols

  At baseline

• Model performance for virtual LGE generation across sequence protocols: Peak Signal-to-Noise Ratio (PSNR)

  At baseline

• Model performance for virtual LGE generation across sequence protocols: DICE coefficient

  At baseline

Interventions

Multi-modal Cardiac Magnetic Resonance DIAGNOSTIC_TEST

A comprehensive "one-stop" scanning protocol using 3.0T MRI scanners. The protocol includes Cine imaging, T1/T2 mapping, Late Gadolinium Enhancement (LGE), first-pass perfusion, and 4D flow sequences to evaluate cardiac structure, function, myocardial tissue characteristics, and hemodynamics.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 40486822 BACKGROUND

• 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.

  PMID: 35592889 BACKGROUND

• 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.

  PMID: 28860319 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Ischemia; Cardiomyopathies; Myocarditis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases

Central Study Contacts

jiaqi Fan

CONTACT

+86 15267029492; jqfan@zju.edu.cn

linyun Xie

CONTACT

+86 15990004158; 12518519@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)