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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Superparamagnetic Iron Oxide Nanoparticles

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator