A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of 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 study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Calcification
• Intervention / Treatment: Drug: Superparamagnetic Iron Oxide Nanoparticles

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Chunjian Li, Phd、MD; Phone Number: +86 13701465229; Email: lijay@njmu.edu.cn
• Study Contact Backup: Name: Qin Wang; Phone Number: +86 15651646136; Email: wq_0905@sina.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • First Affiliated Hospital of Nanjing Medical University
      • Contact: Chunjian Li, Phd、MD; Phone Number: +86 13701465229; Email: lijay@njmu.edu.cn
      • Contact: Qin Wang; Phone Number: +86 15651646136; Email: wq_0905@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100 patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen at the First Affiliated Hospital of Nanjing Medical University.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with calcified lesions; A novel ferumoxytol-enhanced cardiac magnetic resonance imaging and coronary angiography are performed in patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen.	Drug: Superparamagnetic Iron Oxide Nanoparticles; Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.; Other Names: Ferumoxytol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of vascular stenosis at the site of coronary calcification.	Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen	①CT-FFR: computed tomography fractional flow reserve. ②Agatston score:0 point: No calcification; 1 to 10 points: Minimal plaque burden; 11 to 100 points: Mild plaque burden; 101 to 400 points: Moderate plaque burden; Greater than 400 points: Extensive plaque burden. ③the angle of calcification lesions occupying vascular lumen (CCTA)：0°-360°	baseline
calcium score of the plaque measured by OCT	OCT: calcium score of the plaque (①Calcification angle: the angle of the calcified plaque surrounding the vessel wall, a larger angle indicates more severe calcification. ②Calcification length: the longitudinal extension length of the calcified plaque along the vessel. ③Calcification thickness: the maximum thickness of the calcified plaque).	baseline
Fe-CMRA image quality score	Fe-CMRA image quality score: the image quality was assessed by a 4-point scale: 1=poor (coronary vessel barely evident or noisy image); 2=moderate (coronary vessel visible but diagnostic confidence low); 3=good (coronary artery adequately visualized and diagnostic quality image); and 4=excellent (coronary artery clearly depicted).	baseline

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Chunjian Li, Phd、MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 25, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Ferumoxytol; Coronary Artery Calcification; Ultrasmall Superparamagnetic Iron Oxide Particles
• Additional Relevant MeSH Terms: Inorganic Chemicals; Manufactured Materials; Technology, Industry, and Agriculture; Ferric Compounds; Iron Compounds; Ferrous Compounds; Minerals; Nanostructures; Metal Nanoparticles; Nanoparticles; Ferrosoferric Oxide; Magnetic Iron Oxide Nanoparticles
• Other Study ID Numbers: 028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No