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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: jiaqi Fan
- Telefonnummer: +86 15267029492
- E-Mail: jqfan@zju.edu.cn
Studieren Sie die Kontaktsicherung
- Name: linyun Xie
- Telefonnummer: +86 15990004158
- E-Mail: 12518519@zju.edu.cn
Studienorte
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Rekrutierung
- The Second Affiliated Hospital Zhejiang University School of Medicine
-
Kontakt:
- jiaqi Fan
- Telefonnummer: +86 15267024942
- E-Mail: jqfan@zju.edu.cn
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diagnostic Efficacy of Multi-modal CMR Parameters (AUC)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation Between Imaging Parameters and Clinical Indicators
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 谢明星, 王睿 & 张丽. 多模态影像在心脏疾病诊疗中的应用与进展. 临床心血管病杂志 36, 1071-1074 (2020).
- 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.
- 国家心血管病中心, 中国心血管健康与疾病报告编写组 & 胡盛寿. 中国心血管健康与疾病报告 2024 概要. 中国循环杂志 40, 521-559 (2025).
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 研2026-0319
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Multi-modal Cardiac Magnetic Resonance
-
Centre Hospitalier Universitaire de Saint EtienneAbgeschlossen
-
Oliver StrohmBayerAbgeschlossenKardiomyopathie, erweitert | Kardiomyopathien, sekundärKanada
-
LIU WEIMINNoch keine Rekrutierung
-
VA Office of Research and DevelopmentAbgeschlossenFettleibigkeit | DysmobilitätVereinigte Staaten