Coronary Artery Calcification
Conditions
Keywords
Ferumoxytol, Magnetic Resonance Imaging, Ultrasmall Superparamagnetic Iron Oxide Particles, Coronary Artery Calcification
Brief 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.
Interventions
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, \<75 years; 2. 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); 3. Patient who will undergo coronary angiography; 4. Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3; 5. Patient who signs the informed consent.
Exclusion criteria
1. People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves; 2. 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; 3. suffering from terminal diseases (such as malignant tumors) or life expectancy \< 1 year; 4. Pregnant or lactating women; 5. People with limited hearing; 6. Patients with grade III-IV heart function; 7. Patients with a history of coronary artery stent implantation or coronary artery bypass; 8. Other iron agents are being used orally or intravenously; 9. Patients with hemosiderosis or hemochromatosis; 10. Patients with acute coronary syndrome; 11. Patients with hyperthyroidism; 12. Any other candidates deemed unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of vascular stenosis at the site of coronary calcification. | baseline | Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen | 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° |
| calcium score of the plaque measured by OCT | 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). |
| Fe-CMRA image quality score | 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). |
Countries
China
Contacts
CONTACTChunjian Li, Phd、MD
CONTACTQin Wang
PRINCIPAL_INVESTIGATORChunjian Li, Phd、MD
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed