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New MRI technique could spot hidden heart risks without radiation

NCT ID NCT07400406

Diagnosis Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new MRI technique that uses a special iron-based contrast agent (ferumoxytol) to detect calcium buildup in heart arteries. Researchers will compare this method to standard CT scans in 100 adults with known calcified arteries. The goal is to see if the MRI can accurately measure artery blockages, potentially offering a radiation-free alternative for diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferumoxytol (iron oxide nanoparticles)
What this could lead to
If successful, this could offer a more accurate, radiation-free way to diagnose coronary artery calcification, potentially improving heart disease detection.
What could go wrong
This is an early-stage, single-center study with only 100 participants. The new MRI method may not prove more accurate than existing CT scans, and ferumoxytol can cause allergic reactions or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery calcification

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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