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New research aims to solve mystery of bony plaques that cause heart attacks

NCT ID NCT07262359

Knowledge-focused Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is looking at a specific type of hard plaque in heart arteries called a calcified nodule, which can cause sudden heart attacks and is hard to treat. Researchers will use special cameras inside the arteries to see these plaques in detail and track how patients do over time. The goal is to learn more about these plaques to help doctors treat them better in the future.

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 500 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2031

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

Age: ≥ 18 years old. Clinical Presentation: Patient presents with stable coronary artery disease, unstable angina, or an acute coronary syndrome (including NSTEMI and STEMI) and is scheduled to undergo coronary angiography and percutaneous coronary intervention (PCI). Intravascular Imaging Indication: The use of intravascular imaging (IVUS or OCT) is clinically indicated and used during the PCI procedure at the discretion of the operating interventional cardiologist. Common clinical indications include: Assessment of lesion severity and morphology. Guidance for stent sizing and optimization. Evaluation of complex lesions (e.g., calcified, long, bifurcation lesions). Target Lesion Identification: The use of IVUS or OCT must identify the presence of a calcified nodule (CN) in at least one native coronary artery lesion. The CN must be confirmed by the core lab according to standardized definitions:

Ages

18 years and older

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: * The patient must be at least 18 years old. Intracoronary imaging confirms the presence of at least one calcified nodule lesion. The patient is willing and able to comply with the study procedures and follow-up until the study concludes. The subject confirms understanding of the study's risks, benefits, and alternative treatments, and has signed the informed consent form approved by the ethics committee prior to any protocol-related procedures. Exclusion Criteria: Contraindication to Procedure: Known contraindication to coronary angiography, PCI, or adjunctive pharmacologic therapy (e.g., aspirin, P2Y12 inhibitors, heparin, contrast media) that cannot be adequately managed with standard medical care. Life Expectancy: Life expectancy of less than 1 year due to non-cardiac comorbid conditions (e.g., active malignancy, advanced organ failure). Inability to Follow-Up: Inability or unwillingness to comply with the study protocol or scheduled follow-up visits.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Coronary artery atherosclerosis Coronary artery disease Coronary calcification Coronary calcified nodules

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.