First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000, China
Location status: Recruiting
Location contact
Chunjian Li, Phd、MD
CONTACT
Qin Wang
CONTACT
NCT Number: NCT07400406
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Nanjing, Jiangsu, 210000, China
Location status: Recruiting
Chunjian Li, Phd、MD
CONTACT
Qin Wang
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
Other names: Ferumoxytol
Time frame: baseline
Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%.
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°
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).
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).
Contact information is provided by the study sponsor or research team.
Chunjian Li, Phd、MD
CONTACT
Qin Wang
CONTACT
The First Affiliated Hospital with Nanjing Medical University
Other
Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
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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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