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New study aims to uncover why some heart disease worsens quickly due to inflammation

NCT ID NCT06007248

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a fast-progressing type of coronary artery disease that may be driven by inflammation. Researchers will compare 20 patients with this condition to 10 patients with typical heart disease, using lab tests, imaging, and physical assessments. The goal is to better understand what makes this form of heart disease different, which could lead to earlier detection and more tailored care.

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 help doctors better identify and treat a fast-progressing form of heart disease linked to inflammation.
What could go wrong
This is a small, early observational study with only 30 participants, so findings may not apply to all patients. It does not test a new treatment.

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 30 people

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

Started

Nov 2023

Expected to finish

Sep 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

The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.

Ages

45 to 64 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: Case group (IR-CAD patients): 1. 18 years of age or older, male or female. 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 3. Prior history of coronary revascularization (PCI or coronary artery bypass graft \[CABG\]). 4. Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization. 5. Hospitalization due to rapidly-progressive myocardial ischemia: * Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and * Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization. 6. Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia. 7. Evidence of inflammation: * At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein \[hs-CRP\], interleukin \[IL\]-6, tumor necrosis factor \[TNF\]-α, ferritin, et al); or * Established diagnosis of systemic autoimmune disease or systemic vasculitis; or * Receiving immunosuppressive therapy. Control group (AS-CAD patients): 1. ≥ 45 and \< 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female. 2. Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile). 3. Currently, 12±6 months after the last PCI. 4. Receiving standard treatment for secondary prevention of AS-CAD after the last PCI. 5. Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization. 6. No evidence of rapidly-progressive myocardial ischemia, which is defined as follows: * Typical symptoms of angina (Canadian Cardiovascular Society \[CCS\] III-IV) and non-invasive evidence of myocardial ischemia; and * Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI. 7. No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia. Exclusion Criteria: Case group (IR-CAD patients): 1. Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al). 2. Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al). 3. Active acute or chronic infection (human immunodeficiency virus \[HIV\], tuberculosis, et al). 4. Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment). 5. Vital organ failure. 6. Life expectancy \< 1 year. 7. Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents. 8. In pregnancy or breast-feeding, or with intention to be pregnant during the study period. 9. Risk of non-compliance (history of drug addiction or alcohol abuse, et al). 10. Previous enrollment in this study. 11. Participation in another study within 30 days. 12. Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al). 13. Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study. Control group (AS-CAD patients): The same as those for the case group (IR-CAD patients).

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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

    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

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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