Status:
RECRUITING
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Heart Aneurysm
Eligibility:
All Genders
18-80 years
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 routi...
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 approve...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
November 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06146751
Start Date
November 6 2023
End Date
March 31 2025
Last Update
September 23 2024
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029