A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries

NCT07400406 | Recruiting DMC

• 1 other identifier: 028
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Calcification

Keywords

Ferumoxytol; Magnetic Resonance Imaging; Ultrasmall Superparamagnetic Iron Oxide Particles; Coronary Artery Calcification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen

  baseline

• calcium score of the plaque measured by OCT

  baseline

• Fe-CMRA image quality score

  baseline

Study Arms (1)

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

Interventions

Superparamagnetic Iron Oxide Nanoparticles DRUG

Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.

Also known as: Ferumoxytol

patients with calcified lesions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years, \<75 years;
• 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);
• Patient who will undergo coronary angiography;
• Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;
• Patient who signs the informed consent.

You may not qualify if:

• People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;
• 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;
• suffering from terminal diseases (such as malignant tumors) or life expectancy \< 1 year;
• Pregnant or lactating women;
• People with limited hearing;
• Patients with grade III-IV heart function;
• Patients with a history of coronary artery stent implantation or coronary artery bypass;
• Other iron agents are being used orally or intravenously;
• Patients with hemosiderosis or hemochromatosis;
• Patients with acute coronary syndrome;
• Patients with hyperthyroidism;
• Any other candidates deemed unsuitable by the researchers.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

Magnetic Iron Oxide Nanoparticles; Ferrosoferric Oxide

Intervention Hierarchy (Ancestors)

Metal Nanoparticles; Nanoparticles; Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Chunjian Li, Phd、MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjian Li, Phd、MD

CONTACT

+86 13701465229; lijay@njmu.edu.cn

Qin Wang

CONTACT

+86 15651646136; wq_0905@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 10, 2026
• Study Start: January 26, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)