Chronic Kidney Disease Clinical Trials

Find Chronic Kidney Disease Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Chunjian Li, MD, PhD
lijay@njmu.edu.cn
+86-13701465229
Backup
Zhenyu Lin, MD
lzydoctor@126.com
+86-18262712770
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 320
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov