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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with calcified lesions | A novel ferumoxytol-enhanced cardiac magnetic resonance imaging and coronary angiography are performed in patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superparamagnetic Iron Oxide Nanoparticles | Drug | Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of vascular stenosis at the site of coronary calcification. | Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen | 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° |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen at the First Affiliated Hospital of Nanjing Medical University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunjian Li, Phd、MD | Contact | +86 13701465229 | lijay@njmu.edu.cn | |
| Qin Wang | Contact | +86 15651646136 | wq_0905@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunjian Li, Phd、MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D000082662 | Magnetic Iron Oxide Nanoparticles |
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D053768 | Metal Nanoparticles |
| D053758 | Nanoparticles |
| D049329 | Nanostructures |
| D008420 | Manufactured Materials |
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|
| baseline |
| calcium score of the plaque measured by OCT | 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). | baseline |
| Fe-CMRA image quality score | 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). | baseline |
| D013676 |
| Technology, Industry, and Agriculture |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |