Clinical Features, Current Treatment and Clinical Outcomes in Patients With INR-CAD: a Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older, male or female.

Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).

Meeting the clinical diagnostic criteria for INR-CAD, including: (1) Angiographic evidence of coronary lesions (≥ 50% diameter stenosis, de novo or restenotic); (2) Evidence of chronic inflammation within 24 months: (A) Positive inflammatory markers (erythrocyte sedimentation rate [ESR], high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α], et al; at least twice, ≥ 12 weeks apart), or (B) Positive autoantibodies (at least twice, ≥ 12 weeks apart), or (C) Established diagnosis of chronic inflammatory diseases (autoimmune disease, systemic vasculitis, psoriasis, tuberculosis, et al), or (D) Receiving immunosuppressive therapy (glucocorticoids, immunosuppressive agents, et al).

NOT meeting the clinical diagnostic criteria for IR-CAD, including: (1) Hospitalization due to myocardial ischemia, including: (A) Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV), and (B) Non-invasive evidence of myocardial ischemia; (2) Angiographic evidence of new or worsened coronary lesions (de novo or restenotic) considered relevant to myocardial ischemia, which occurred: (A) Within 6 months of last coronary angiography in any patients, or (B) Within 12 months of last coronary angiography in patients receiving immunosuppressive therapy within 24 months.

Disqualifiers

Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).

Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).

Vital organ failure.

Life expectancy < 1 year.

Trial population

All patients who have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since January 1, 2022 will be screened for study participation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Healthy life style

    Behavioral

    Healthy diet, regular exercise, and quitting smoking

  • Secondary prevention for atherosclerotic coronary artery disease

    Drug

    Antiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose

  • Immunosuppressive Therapy

    Drug

    Glucocorticoids and/or immunosuppressive agents

  • Coronary revascularization

    Procedure/Surgery

    Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).

  • Supportive therapies

    Drug

    Medical interventions for prevention and treatment of the side effects of the above treatment, such as abnormal liver function, hypocalcemia, hypokalemia, peptic ulcer, infection, et al.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: INR-CAD Group5 interventions

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events (MACE)

The composite endpoint including death, or Q-wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

Secondary outcomes

1

Death

All-cause death.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
2

Q-wave myocardial infarction

Myocardial injury due to myocardial ischemia, resulting in newly formed pathological Q waves in ≥ 2 contiguous leads or equivalent manifestations on electrocardiogram.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
3

Unplanned myocardial ischemia-driven coronary revascularization

Unplanned coronary revascularization (PCI or CABG) due to myocardial ischemia.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
4

Unplanned myocardial ischemia-driven hospitalization

Unplanned hospitalization due to myocardial ischemia.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

Other outcomes

1

Major bleeding events

Major bleeding events evaluated according to the Bleeding Academic Research Consortium (BARC) criteria.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
2

Severe infection events

Infection events involving vital organs, or with complications (such as structural change and/or dysfunction of vital organs, septic shock, et al), or requiring hospitalization, or requiring treatment with intravenous antibiotics, or requiring treatment with interventional procedures or surgeries.

Time frame
From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.

Sponsors and contacts

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