Ferumoxytol-enhanced heart MRI to find calcified coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.