Actively Recruiting
Using Ferumoxytol-Enhanced Cardiac MRI to Detect Blood Clots in Patients with Heart Ventricular Aneurysm and After Ventricular Reconstruction
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-09-23
320
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging method using ferumoxytol-enhanced cardiac magnetic resonance imaging MRI to detect blood clots inside the heart in patients with ventricular aneurysm or those who have undergone percutaneous ventricular reconstruction. The study aims to compare this new MRI approach with the commonly used transthoracic echocardiography, which has lower accuracy in detecting these clots. Ferumoxytol is an iron-based contrast agent that may offer safer and more effective imaging, especially for patients with kidney problems. Participants will receive the ferumoxytol-enhanced cardiac MRI along with a transthoracic echocardiography for comparison. The ferumoxytol contrast agent has a long blood circulation time, allowing for detailed and repeated MRI scans. This observational study is non-randomized and includes patients with ventricular aneurysm or those about 180 days after percutaneous ventricular reconstruction. Experts will review imaging results independently to evaluate detection rates. During the study, participants will undergo imaging tests to detect intracardiac thrombus and assess thrombus presence in both dynamic and static heart chambers. Researchers will measure the detection rates of clots from November 2023 to March 2025. The study includes monitoring for safety and tolerability related to the contrast agent. Participants will be involved in scheduled imaging and clinical assessments over the study period.
CONDITIONS
Brief Title
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older, up to 80 years
- Patients with left ventricular aneurysm detected by transthoracic echocardiography
- Patients about 180 days after percutaneous ventricular reconstruction
- Signed informed consent by the patient or authorized family member
You will not qualify if you...
- Unable to lie down for any reason
- Unable to undergo MRI due to psychological or physical reasons, such as claustrophobia or presence of non-antimagnetic metal in the body
- Known history of iron allergy or hypersensitivity
- Currently taking other oral or intravenous iron products
- Presence of haemosiderin deposition or haemochromatosis
- Pregnant or lactating women
- Any other condition deemed inappropriate for enrollment by the investigator
Research Team
C
Chunjian Li, MD, PhD
Z
Zhenyu Lin, MD
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