Coronary Heart DiseasePhase 1NCT05032937

the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

A Phase 1 study testing domestic polysaccharide superparamagnetic iron oxide nanoparticle in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 13 Oct 2021to 5 Jan 2023
Phase: Phase 1
Are there results?: None posted in the registry

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

Who may be able to join

Age ≧ 18 years, < 75 years;
Patients who planned coronary angiography ;
Patients with normal renal function or CKD stage 1-3;
Patients themselves or authorized families to sign informed consent voluntarily.

Who cannot join

Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );
Malignancies or other comorbid conditions with life expectancy less than 1 year;
Pregnant or lactating woman;
Hearing impaired persons;
Cardiac function grade III-IV;

Show all 11Show fewer

History of coronary stenting or coronary artery bypass grafting;
Patients who were taking other iron agents orally or intravenously;
Patients with hemosiderin deposition or hemochromatosis;
Patients with acute coronary syndromes;
Any other patients that researcher deems it's unsuitable to be admitted.

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography

This is a single-center, prospective, controlled and diagnostic clinical trial which will enroll 30 patients scheduled for coronary angiography in China.Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The main indicators of the study are the degree of coronary artery stenosis and the stability of coronary atherosclerotic plaque assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.

Conditions: Coronary Heart Disease
Being tested: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Plaque Stability
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

domestic polysaccharide superparamagnetic iron oxide nanoparticleDrug
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Study groups in NCT05032937
Study group	Role	What they receive
ECMR	Experimental	Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography. Receives: Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle

What is being measured

The primary outcome is the main question the study is designed to answer.

The degree of coronary artery stenosis
Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Measured: baseline
The degree of coronary artery stenosis
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Measured: 72 hours
Plaque stability of coronary atherosclerotic plaques
Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Measured: baseline
Plaque stability of coronary atherosclerotic plaques
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Measured: 72 hours
Blood routine
Blood routine examination of patients before and after examination to evaluate general condition of patients.
Measured: baseline,72 hours,30 Days,3 months
Blood biochemistry
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Measured: baseline,72 hours,30 Days,3 months
Urine routine
Urine routine examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 Days,3 months
24-hour urine biochemistry
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 Days,3 months
Retinol binding protein
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 Days,3 months
Serum iron
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 Days,3 months
Ferritin
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 Days,3 months
Transferrin
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 Days,3 months
Change of iron content in tissues between different time points
Evaluation of tissue iron content by T1W MRI before and after ECMR.
Measured: baseline,6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 20215 Jan 2023

First posted2 Sep 2021
Study start13 Oct 2021
Primary completion5 Nov 2022
Study completion5 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies 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: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05032937
Sponsor's protocol ID: 012
Status last verified: Jan 2023
First submitted: 21 Aug 2021
Last updated: 13 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

He J, Qian W, Dong Z, Li C, Gu N, Zhu X, Xu Y. Improvement of image quality and diagnostic accuracy of novel ferumoxytol-enhanced magnetic resonance coronary angiography: compared to non-contrast enhanced imaging. Eur J Radiol. 2026 Oct 4;205:113278. doi: 10.1016/j.ejrad.2026.113278. Online ahead of print.
PubMed 42854505
Dong Z, Si G, Zhu X, Li C, Hua R, Teng J, Zhang W, Xu L, Qian W, Liu B, Wang J, Wang T, Tang Y, Zhao Y, Gong X, Tao Z, Xu Z, Li Y, Chen B, Kong X, Xu Y, Gu N, Li C. Diagnostic Performance and Safety of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography. Circ Cardiovasc Imaging. 2023 Jul;16(7):580-590. doi: 10.1161/CIRCIMAGING.123.015404. Epub 2023 Jul 18.
PubMed 37463240
Kar A, Gupta S, Matilal A, Kumar D, Sarkar S. Nanotherapeutics for the Myocardium: A Potential Alternative for Treating Cardiac Diseases. J Cardiovasc Pharmacol. 2023 Sep 1;82(3):180-188. doi: 10.1097/FJC.0000000000001444.
PubMed 37341530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography
ClinicalTrials.gov ID: NCT05032937
Acronym / sponsor ID: 012
Conditions: Coronary Heart Disease
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Plaque Stability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study start: 13 Oct 2021 (actual)
Primary completion: 5 Nov 2022 (actual)
Study completion: 5 Jan 2023 (actual)
First posted: 2 Sep 2021 (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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ECMR	Experimental	Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticlePatients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≧ 18 years, < 75 years;
Patients who planned coronary angiography ;
Patients with normal renal function or CKD stage 1-3;
Patients themselves or authorized families to sign informed consent voluntarily.

Key exclusion criteria (11 listed)

Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );
Malignancies or other comorbid conditions with life expectancy less than 1 year;
Pregnant or lactating woman;
Hearing impaired persons;

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
domestic polysaccharide superparamagnetic iron oxide nanoparticlePatients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.	Drug	ECMR

Primary outcome

The degree of coronary artery stenosis
Time frame: baseline
Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
The degree of coronary artery stenosis
Time frame: 72 hours
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Plaque stability of coronary atherosclerotic plaques
Time frame: baseline
Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Plaque stability of coronary atherosclerotic plaques
Time frame: 72 hours
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Blood routine
Time frame: baseline,72 hours,30 Days,3 months
Blood routine examination of patients before and after examination to evaluate general condition of patients.
Blood biochemistry
Time frame: baseline,72 hours,30 Days,3 months
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Urine routine
Time frame: baseline,72 hours,30 Days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
Time frame: baseline,72 hours,30 Days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Retinol binding protein
Time frame: baseline,72 hours,30 Days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
Time frame: baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Serum iron
Time frame: baseline,72 hours,30 Days,3 months
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Ferritin
Time frame: baseline,72 hours,30 Days,3 months
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Transferrin
Time frame: baseline,72 hours,30 Days,3 months
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Change of iron content in tissues between different time points
Time frame: baseline,6 months
Evaluation of tissue iron content by T1W MRI before and after ECMR.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
Derived from this study: PubMed 42854505He J, Qian W, Dong Z, Li C, Gu N, Zhu X, Xu Y. Improvement of image quality and diagnostic accuracy of novel ferumoxytol-enhanced magnetic resonance coronary angiography: compared to non-contrast enhanced imaging. Eur J Radiol. 2026 Oct 4;205:113278. doi: 10.1016/j.ejrad.2026.113278. Online ahead of print.
Derived from this study: PubMed 37463240Dong Z, Si G, Zhu X, Li C, Hua R, Teng J, Zhang W, Xu L, Qian W, Liu B, Wang J, Wang T, Tang Y, Zhao Y, Gong X, Tao Z, Xu Z, Li Y, Chen B, Kong X, Xu Y, Gu N, Li C. Diagnostic Performance and Safety of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography. Circ Cardiovasc Imaging. 2023 Jul;16(7):580-590. doi: 10.1161/CIRCIMAGING.123.015404. Epub 2023 Jul 18.
Derived from this study: PubMed 37341530Kar A, Gupta S, Matilal A, Kumar D, Sarkar S. Nanotherapeutics for the Myocardium: A Potential Alternative for Treating Cardiac Diseases. J Cardiovasc Pharmacol. 2023 Sep 1;82(3):180-188. doi: 10.1097/FJC.0000000000001444.
Individual participant dataSharing planned: No

Related trials for Coronary Heart Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

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. This study is not recruiting at the moment.

Chunjian Li, Dr, PhD principal investigator

Study Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 11 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: finished, as of the sponsor's last update on 13 Jan 2023. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The degree of coronary artery stenosis (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032937, which also lists 3 linked publications.

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 13 Jan 2023.