Using ferumoxytol-enhanced MRI to detect blood clots in heart aneurysms
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction
This study is testing if a new type of MRI using ferumoxytol can better find blood clots in the hearts of people with left ventricular aneurysms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06146751 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the detection of intracardiac thrombus in patients with ventricular aneurysm using ferumoxytol-enhanced cardiac magnetic resonance imaging. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, serves as a safer alternative to traditional gadolinium-based contrast agents, which have associated risks. The study will enroll patients aged 18 to 80 who have been diagnosed with left ventricular aneurysm and will assess the effectiveness of this imaging technique in identifying thrombus presence. The research is being conducted at a single center, focusing on patients who have undergone percutaneous ventricular reconstruction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosed left ventricular aneurysm.
Not a fit: Patients with conditions preventing MRI, such as claustrophobia or metal implants, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of blood clots in heart aneurysm patients, potentially improving treatment outcomes.
How similar studies have performed: While the use of ferumoxytol in MRI is relatively novel, previous studies have shown promising results with similar imaging techniques.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Chunjian Li, MD, PhD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Chunjian Li, MD, PhD
- Email: lijay@njmu.edu.cn
- Phone: +86-13701465229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.