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NCT Number: NCT07400406

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Superparamagnetic Iron Oxide Nanoparticles

Drug

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

Other names: Ferumoxytol

Primary outcomes

  1. Degree of vascular stenosis at the site of coronary calcification.

    Time frame: baseline

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

Secondary outcomes

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

    Time frame: baseline

    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°

  2. calcium score of the plaque measured by OCT

    Time frame: baseline

    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).

  3. Fe-CMRA image quality score

    Time frame: baseline

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chunjian Li, Phd、MD

CONTACT

[email protected]

+86 13701465229

Qin Wang

CONTACT

[email protected]

+86 15651646136

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Registry information

Official study title

Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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