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RECRUITING
NCT06146751

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

320

Start Date

2023-11-06

Completion Date

2025-03-31

Last Updated

2024-09-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Superparamagnetic Iron Oxide Nanoparticles

Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China