Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study

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

About this trial

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Occurred after the last coronary revascularization; and

Related to myocardial ischemia (location, extent, severity, et al).

Disqualifiers

Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).

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

Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).

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

Trial population

All patients who were admitted to the Department of Cardiology, Peking Union Medical College Hospital on and after 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

39 Participants
are divided into 2 treatment groups
Group A: Pre-treatment Group4 interventions
Group B: Post-treatment 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
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.

Secondary outcomes

1

Target vessel related major adverse cardiovascular events (TV-MACE)

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

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
2

Death

All-cause death.

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
3

Myocardial infarction

Myocardial injury due to myocardial ischemia.

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
4

Target vessel related myocardial infarction

Myocardial infarction in the area supplied by the target vessel.

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.

Other outcomes

1

Major bleeding events

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

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.
2

Severe infection events

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

Time frame
Time from the last coronary revascularization to the first occurrence of MACE, or the last follow-up visit, or the end of 24-month follow-up, which occurs first, both before and after the initiation of comprehensive treatment.

Sponsors and contacts

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