Coronary Artery CalcificationNCT07400406
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
An observational study of Coronary Artery Calcification, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Calcification
- What is being tested?
- Superparamagnetic Iron Oxide Nanoparticles
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years, <75 years;
- 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);
- Patient who will undergo coronary angiography;
- Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;
- Patient who signs the informed consent.
Who cannot join
- People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;
- 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;
- suffering from terminal diseases (such as malignant tumors) or life expectancy < 1 year;
- Pregnant or lactating women;
- People with limited hearing;
- Patients with grade III-IV heart function;
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- Patients with a history of coronary artery stent implantation or coronary artery bypass;
- Other iron agents are being used orally or intravenously;
- Patients with hemosiderosis or hemochromatosis;
- Patients with acute coronary syndrome;
- Patients with hyperthyroidism;
- Any other candidates deemed unsuitable by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Chunjian Li, Phd、MD, +86 13701465229, lijay@njmu.edu.cn
Qin Wang, +86 15651646136, wq_0905@sina.com
About this study
Official title: Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
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.
- Conditions
- Coronary Artery Calcification
- Being tested
- Superparamagnetic Iron Oxide Nanoparticles
- Keywords
- Ferumoxytol, Magnetic Resonance Imaging, Ultrasmall Superparamagnetic Iron Oxide Particles, Coronary Artery Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superparamagnetic Iron Oxide NanoparticlesDrug
Also called Ferumoxytol
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Superparamagnetic Iron Oxide Nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: baseline
Secondary outcomes (3)
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°
Measured: 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).
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start26 Jan 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, Phd、MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400406
- Sponsor's protocol ID
- 028
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
- ClinicalTrials.gov ID
- NCT07400406
- Acronym / sponsor ID
- 028
- Conditions
- Coronary Artery Calcification
- Keywords
- Ferumoxytol, Magnetic Resonance Imaging, Ultrasmall Superparamagnetic Iron Oxide Particles, Coronary Artery Calcification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with calcified lesions | – | Drug: Superparamagnetic Iron Oxide NanoparticlesA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age ≥18 years, <75 years;
- 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);
- Patient who will undergo coronary angiography;
- Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;
- Patient who signs the informed consent.
Key exclusion criteria (12 listed)
- People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;
- 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;
- suffering from terminal diseases (such as malignant tumors) or life expectancy < 1 year;
- Pregnant or lactating women;
- People with limited hearing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superparamagnetic Iron Oxide NanoparticlesAlso: FerumoxytolPatients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging. | Drug | patients with calcified lesions |
Primary outcome
Degree of vascular stenosis at the site of coronary calcification.
Time frame: baseline
Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%.
3 secondary outcomes
CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen
Time frame: baseline
calcium score of the plaque measured by OCT
Time frame: baseline
Fe-CMRA image quality score
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunjian Li, Phd、MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Calcification, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunjian Li, Phd、MD (+86 13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of vascular stenosis at the site of coronary calcification. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.