Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07400406

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-02-10

100

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital with Nanjing Medical University

Lead Sponsor

C

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and younger than 75 years
  • Coronary CT angiography images taken within 30 days showing calcification occupying more than 50% of the vascular lumen in major coronary artery segments
  • Planned to undergo coronary angiography
  • Normal kidney function or chronic kidney disease stage 1 to 3
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Allergy to iodine contrast media, iron, or dextran
  • Unable to undergo MRI due to psychological reasons (such as claustrophobia) or physical reasons (such as metal implants)
  • Terminal illness or life expectancy less than 1 year
  • Pregnant or breastfeeding women
  • Hearing impairment
  • Severe heart failure (grade III-IV)
  • History of coronary artery stent placement or bypass surgery
  • Currently using other iron-containing medications
  • Diagnosis of hemosiderosis or hemochromatosis
  • Acute coronary syndrome
  • Hyperthyroidism
  • Any other conditions deemed unsuitable by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

C

Chunjian Li, Phd、MD

CONTACT

Q

Qin Wang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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