A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary A… (NCT07400406) | Clinical Trial Compass
RecruitingNot Applicable
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
China100 participantsStarted 2024-01-26
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
What they're measuring
1
Degree of vascular stenosis at the site of coronary calcification.
Timeframe: baseline
Trial details
NCT IDNCT07400406
SponsorThe First Affiliated Hospital with Nanjing Medical University