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

NCT06146751 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Observational

Started

2023-11-06

Last updated

2024-09-23

Condition(s) studied

Heart Aneurysm

Investigational drug(s) / intervention(s)

Superparamagnetic Iron Oxide Nanoparticles

Superparamagnetic Iron Oxide Nanoparticles: Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion criteria: 1. Age ≥ 18 years and ≤ 80 years; 2. Patients with left ventricular aneurysm detected by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction; 3. An informed consent form was signed voluntarily by the patients or an authorised family member. Exclusion criteria: 1. Patients unable to lie down for any reason; 2. Patients who are unable to undergo MRI for psychological (e.g. suffering from claustrophobia syndrome) or physical reasons (e.g. non-antimagnetic metal retention in the body, hearing impairment, involuntary body movements, etc.); 3. Patients with a known history of iron allergy or hypersensitivity; 4. Patients taking other oral or intravenous iron products; 5. Patients with haemosiderin deposition or haemochromatosis; 6. Pregnant or lactating women; 7. Any other patient that the investigator deems inappropriate for enrolment.

Primary outcome measure(s)

detection rate of intracardiac thrombus — Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of intracardiac thrombus by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography
detection rate of thrombus in dynamic chamber and static chamber — Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of thrombus in dynamic chamber and static chamber by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography in patients after percutaneous ventricular reconstruction

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	Recruiting

More The First Affiliated Hospital with Nanjing Medical University trials in China

Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL Recruiting

SHR2554 as Maintenance Therapy in Patients With Peripheral T-cell Lymphoma Starting soon

Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed/ Refractory DLBCL Starting soon

RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies Recruiting

Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06146751 on ClinicalTrials.gov ↗ ← All trials in China