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

What this Trial Is About

Researchers are evaluating a new imaging method called ferumoxytol-enhanced cardiac magnetic resonance (Fe-CMR) to detect calcified coronary arteries in patients confirmed by coronary CT angiography (CCTA) to have coronary calcified lesions. This single-center, prospective, controlled diagnostic study aims to compare the accuracy of Fe-CMR and CCTA, using coronary angiography (CAG) and optical coherence imaging (OCT) as the gold standards for detection. The study plans to enroll about 100 patients with CCTA-confirmed calcified lesions. Participants will undergo ferumoxytol-enhanced cardiac magnetic resonance imaging along with coronary angiography. The study focuses on patients whose CCTA images show calcification occupying more than 50% of the vascular lumen angle. Patients will receive the study drug, superparamagnetic iron oxide nanoparticles (ferumoxytol), during the imaging procedures to enhance magnetic resonance results. The study does not mention randomization or placebo but involves detailed imaging assessments. During the study, patients will have their vascular stenosis degree at calcification sites measured as the primary outcome. Secondary assessments include CT-derived fractional flow reserve (CT-FFR), Agatston score, lesion angle, plaque calcium score by OCT, and Fe-CMR image quality. The participation includes imaging specialists evaluating CCTA images taken within 30 days, coronary angiography, and MRI scans. Safety and suitability are monitored, including kidney function and allergy history. The study runs until August 2027, with participants aged 18 to 75 years involved.

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