Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06146751

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-09-23

320

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital with Nanjing Medical University

Lead Sponsor

C

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The incidence of thrombosis in ventricular aneurysm was reported to be 35%-40%, which may lead to systemic thromboembolism. Patients with ventricular aneurysm without detectable thrombus are not routinely treated with anticoagulation. Therefore, the accuracy of intracardiac thrombus detection has an important impact on clinical management decisions. Currently, transthoracic echocardiography is the most commonly used method to detect intracardiac thrombus, but its sensitivity and positive predictive value are low. Cardiac magnetic resonance has a higher diagnostic accuracy for intracardiac thrombus, and its sensitivity and positive predictive value are higher than those of transthoracic echocardiography and CT. However, the gadolinium-based contrast agents commonly used for enhanced magnetic resonance imaging have some problems such as nephrogenic systemic fibrosis, gadolinium deposition in the brain, and short imaging time. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, can be used for off-label enhanced magnetic resonance imaging. Its long intravascular half-life makes it suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol is cleared from the blood pool by macrophages of the reticuloendothelial system, mainly in the spleen and lymph nodes. Therefore, ferumoxytol has a favourable safety even in adults and children with end-stage renal failure. The aim of this study is to evaluate the effectiveness of a novel ferumoxytol-enhanced cardiac magnetic resonance in detecting intracardiac thrombus in patients with ventricular aneurysm and after percutaneous ventricular reconstruction.

CONDITIONS

Official Title

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and 80 years or younger
  • Diagnosed with left ventricular aneurysm by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction
  • Signed informed consent form voluntarily by the patient or an authorized family member
Not Eligible

You will not qualify if you...

  • Unable to lie down for any reason
  • Unable to undergo MRI due to psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-antimagnetic metal in the body, hearing impairment, involuntary movements)
  • Known history of iron allergy or hypersensitivity
  • Currently taking other oral or intravenous iron products
  • Presence of haemosiderin deposition or haemochromatosis
  • Pregnant or lactating women
  • Any other condition deemed inappropriate for enrollment by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

C

Chunjian Li, MD, PhD

CONTACT

Z

Zhenyu Lin, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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