NCT07400406 A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
| NCT ID | NCT07400406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Coronary Artery Calcification |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-26 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Chunjian Li, Phd、MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07400406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Coronary Artery Calcification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07400406 currently recruiting?
Yes, NCT07400406 is actively recruiting participants. Contact the research team at lijay@njmu.edu.cn for enrollment information.
Where is the NCT07400406 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07400406 clinical trial?
NCT07400406 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Chunjian Li, Phd、MD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 100 participants.