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

NCT ID: NCT06146751

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2025-03-31

Brief 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.

Detailed Description

Ferumoxytol is a member of ultrasmall superparamagnetic iron oxide particles with an average diameter of 30 nm, originally developed as an intravascular contrast agent for MRI. Ferumoxytol was approved by the FDA in 2009 for the intravenous treatment of iron deficiency anaemia in adults with chronic kidney disease, and has also been used off-label as a non-gadolinium contrast agent for whole-body magnetic resonance imaging. Its iron oxide core is coated with dextran, which reduces immunogenicity and delays phagocytosis and the release of elemental iron from the core. As a result, ferumoxytol has a long intravascular half-life of approximately 15 hours and is slowly taken up by the macrophages of the reticuloendothelial system. Because of its long half-life, ferumoxytol is suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol has been proved to be safe even in adults and children with end-stage renal failure. As feraheme is not available in the Chinese market, we experimentally synthesised a new formulation of ferumoxytol, which is identical to ferumoxytol in terms of physicochemical structure, pharmacokinetics and toxicological effects, at the request of Chia Tai Tianqing Pharmaceutical Group Co, Ltd (Nanjing, China) in 2014. This study is a single-centre, prospective, observational, non-randomised study. The study will enrol patients with ventricular aneurysm and after percutaneous ventricular reconstruction. The aim of this study is to evaluate the effectiveness of ferumoxytol-enhanced cardiac magnetic resonance imaging in detecting intracardiac thrombus in patients with ventricular aneurysm and left ventricular thrombus in the dynamic chamber and static chamber in patients 180±30 days after percutaneous ventricular reconstruction by comparing the detection rate of intracardiac thrombus with ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography, and to provide a clinical basis for the development and application of the new generation of magnetic resonance contrast agents in China. The echocardiography and magnetic resonance imaging experts were blinded to each other's results.

Conditions

Heart Aneurysm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with ventricular aneurysm and after percutaneous ventricular reconstruction

Patients with ventricular aneurysm and after percutaneous ventricular reconstruction undergo a novel ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography.

Superparamagnetic Iron Oxide Nanoparticles

Intervention Type: DRUG

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

Interventions

Superparamagnetic Iron Oxide Nanoparticles

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

Intervention Type: DRUG

Other Intervention Names

ferumoxytol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunjian Li

Dr., MD, PhD, Deputy Director, Department of Cardiology; Director, Coronary Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunjian Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunjian Li, MD, PhD

Role: CONTACT

lijay@njmu.edu.cn

+86-13701465229

Zhenyu Lin, MD

Role: CONTACT

lzydoctor@126.com

+86-18262712770

Facility Contacts

Chunjian Li, MD, PhD

Role: primary

lijay@njmu.edu.cn

+8613701465229

Zhenyu Lin, MD

Role: backup

lzydoctor@126.com

+8618262712770

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Other Identifiers

024

Identifier Type: -

Identifier Source: org_study_id