Ferumoxytol-enhanced heart MRI to find calcified coronary arteries
Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
This research will see if ferumoxytol-enhanced heart MRI can detect calcified coronary arteries in adults who already have calcification on coronary CT angiography.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07400406 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, controlled diagnostic study plans to enroll about 100 adults with coronary CT angiography (CCTA)-confirmed calcified coronary lesions. Participants will undergo ferumoxytol-enhanced cardiac magnetic resonance imaging (Fe-CMR) using ultrasmall superparamagnetic iron oxide particles, and findings will be compared with CCTA. Coronary angiography (CAG) and optical coherence tomography (OCT) will be used as the reference standards to determine how accurately Fe-CMR and CCTA detect calcified segments. The study includes patients with normal renal function or CKD stages 1–3 and excludes those with MRI contraindications, iron/dextran allergy, pregnancy, or limited life expectancy.
Who should consider this trial
Good fit: Adults aged 18–74 with CCTA-confirmed coronary calcified lesions who are scheduled for coronary angiography, have normal renal function or CKD stage 1–3, can undergo MRI, and have no iron/dextran allergy are the intended participants.
Not a fit: Patients who are pregnant, have severe kidney disease (beyond CKD stage 3), have MRI-incompatible implants or severe claustrophobia, or have a history of allergy to iron or dextran are unlikely to be eligible or benefit from this approach.
Why it matters
Potential benefit: If successful, Fe-CMR could provide a non-ionizing imaging option that may improve detection of coronary calcification and expand safe imaging choices for patients, including some with mild-to-moderate kidney disease.
How similar studies have performed: Ferumoxytol and other ultrasmall iron particles have been used successfully as MRI vascular contrast agents, but applying ferumoxytol specifically to detect coronary calcification is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years, \<75 years; 2. Imaging specialists evaluate CCTA images taken within 30 days and report that calcification occupied one or more of the patient's vascular lumen at an angle of \>50% (using the coronary artery segmentation method recommended by the American Heart Association, including nine segments of the major branches of the coronary artery); 3. Patient who will undergo coronary angiography; 4. Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3; 5. Patient who signs the informed consent. Exclusion Criteria: 1. People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves; 2. Because of psychological (such as suffering from claustrophobic syndrome) or physical reasons (such as the presence of metal objects in the body) can not receive MRI examination; 3. suffering from terminal diseases (such as malignant tumors) or life expectancy \< 1 year; 4. Pregnant or lactating women; 5. People with limited hearing; 6. Patients with grade III-IV heart function; 7. Patients with a history of coronary artery stent implantation or coronary artery bypass; 8. Other iron agents are being used orally or intravenously; 9. Patients with hemosiderosis or hemochromatosis; 10. Patients with acute coronary syndrome; 11. Patients with hyperthyroidism; 12. Any other candidates deemed unsuitable by the researchers.
Where this trial is running
Nanjing, Jiangsu
- First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Chunjian Li, Phd、MD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Chunjian Li, Phd、MD
- 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.