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New study aims to decode heart attack risks by analyzing plaque and immune cells

NCT ID NCT06489119

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at different types of plaque in the arteries of people with coronary artery disease. Researchers will use special imaging to see the plaque and analyze blood cells at a detailed level. The goal is to understand how plaque features relate to immune responses and future heart problems. 350 participants will be followed over time to track major heart events.

What this could mean

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

What this could lead to
If successful, this study could lead to better ways to predict heart attacks by linking plaque features with immune system markers.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care, and results might not apply to all populations.

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 350 people

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

Started

Jul 2024

Expected to finish

Jul 2026

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

Subjects who meet the preset inclusion criteria for each group of people, understand the research requirements and treatment procedures, and sign the informed consent.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Male or female, Age ≥ 18 years and ≤ 85 years. 2. Ability to understand the requirements of the study and to provide informed consent. Control group: Patients with coronary angiographic diameter stenosis \<20%. Stable plaque group: 1. Have been clinically stable for at least 6 months. 2. Presence of ≥1 lesion with angiographic diameter stenosis \>50% with no TCFA lesions in the most severely narrowed native coronary artery (target vessel). TCFA was defined as a lipidic plaque with the thinnest FCT \<75 mm and maximum lipid arc \>180°. 3. Rule out elevation of troponin or myocardial enzymology. Vulnerable plaque group: 1. Have been clinically stable for at least 6 months. 2. Presence of ≥1 lesion with angiographic diameter stenosis \>50% with TCFA lesions in the most severely narrowed native coronary artery (target vessel). 3. Rule out elevation of troponin or myocardial enzymology. Plaque rupture group: 1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of \>0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK/CK-MB above upper reference value. 2. Exist clearly identified culprit lesion. 3. Plaque rupture was defined by the presence of a discontinuity of the fibrous cap with a cavity formed inside the plaque. Plaque erosion group: 1. Persistent chest pain for 30 minutes, arrival at the hospital within 24 hours from symptom onset. ST-segment elevation of \>0.1 mV in ≥2 contiguous leads or new-onset left bundle branch block, and high sensitive Troponin T or I or CK/CK-MB above upper reference value. 2. Exist clearly identified culprit lesion. 3. Plaque erosion was defined by the presence of the attached thrombus overlying the intact fibrous cap of the atherosclerotic plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcium at the site of the thrombus. Exclusion Criteria: 1. Cardiogenic shock or circulatory depression,life-threatening arrhythmia. 2. Known systolic heart failure with LVEF ≤30%. 3. Severe systemic diseases (end-stage renal disease, serious liver dysfunction, chronic active inflammatory diseases, active oncologic diseases, autoimmune diseases). 4. Septicemia, acute inflammatory event with fever. 5. Patients with organ transplants or patients on the waiting list for an organ transplant. 6. Previous CABG treatment, PCI treatment of the target vessel, and PCI treatment of non-target vessels within 1 year. 7. Thrombolysis before PCI. 8. Stenosis of the left main artery ≥50%. 9. Characteristics rendering high-quality OCT imaging unlikely such as chronic total occlusion, pronounced tortuosity, heavily calcified vessels. 10. Infarcted vessel with a diameter \>4mm or \<2.5mm. 11. "No-reflow" (TIMI 0-1) after thrombus aspiration or predilatation. 12. Other subjects deemed unsuitable for study by investigators.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • China-Japan Union Hospital of Jilin

    RECRUITING

    Changchun, Jilin, 130033, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150081, China

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