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

NCT06146751 | Recruiting DMC

• 1 other identifier: 024
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Aneurysm

Keywords

ferumoxytol; ultrasmall superparamagnetic iron oxide particles; contrast-enhanced magnetic resonance; thrombosis; ventricular aneurysm

Outcome Measures

Primary Outcomes (2)

• detection rate of intracardiac thrombus

  Detection rate of intracardiac thrombus by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography

  Nov. 1st, 2023 to Mar. 31st, 2025

• detection rate of thrombus in dynamic chamber and static chamber

  Detection rate of thrombus in dynamic chamber and static chamber by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography in patients after percutaneous ventricular reconstruction

  Nov. 1st, 2023 to Mar. 31st, 2025

Study Arms (1)

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.

Drug: Superparamagnetic Iron Oxide Nanoparticles

Interventions

Superparamagnetic Iron Oxide Nanoparticles DRUG

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

Also known as: ferumoxytol

patients with ventricular aneurysm and after percutaneous ventricular reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 patients with ventricular aneurysm and 10 to 20 patients after percutaneous ventricular reconstruction at the First Affiliated Hospital of Nanjing Medical University

You may qualify if:

• Age ≥ 18 years and ≤ 80 years;
• Patients with left ventricular aneurysm detected by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction;
• An informed consent form was signed voluntarily by the patients or an authorised family member.

You may not qualify if:

• Patients unable to lie down for any reason;
• 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.);
• Patients with a known history of iron allergy or hypersensitivity;
• Patients taking other oral or intravenous iron products;
• Patients with haemosiderin deposition or haemochromatosis;
• Pregnant or lactating women;
• Any other patient that the investigator deems inappropriate for enrolment.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Heart Aneurysm; Thrombosis

Interventions

Magnetic Iron Oxide Nanoparticles; Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Metal Nanoparticles; Nanoparticles; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Chunjian Li, MD, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjian Li, MD, PhD

CONTACT

+86-13701465229; lijay@njmu.edu.cn

Zhenyu Lin, MD

CONTACT

+86-18262712770; lzydoctor@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., MD, PhD, Deputy Director, Department of Cardiology; Director, Coronary Care Unit

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 27, 2023
• Study Start: November 6, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)