RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

ConditionhsCRP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

Coronary heart disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular events (MACE).

At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Foreign studies indicate that hsCRP ≥ 2mg / L is the definition standard of RIR in CAD. In China, there is no defined value of RIR for patients undergoing PCI, and the incidence of RIR has not been investigated clearly. At the same time, the impact of dynamic changes of hsCRP on MACE in PCI population needs to be further explored. Therefore, in this study, we plan to recruit patients undergoing PCI, and observe the impact of RIR by serial hsCRP measurements on the prognosis of these patients followed up for 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who understand and sign the informed consent form voluntarily;

Age ≥ 18 years old and ≤ 80 years old, regardless of sex;

The hospitalized patients with coronary heart disease undergoing PCI;

Complete all planned PCI during hospitalization

Disqualifiers

Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease;

Uncontrolled infectious diseases during the screening period;

In the screening stage, patients with immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on;

Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period;

Trial population

Patients with coronary heart disease completed all planned PCI during hospitalization

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Major adverse cardiovascular events (MACEs)

Composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and revascularization due to ischemia

Time frame
60 months

Secondary outcomes

1

All-cause death

Death due to any cause

Time frame
60 months
2

Cardiovascular death

Death due to cardiovascular cause

Time frame
60 months
3

Nonfatal myocardial infarction

According to the fourth edition of the General Definition of Myocardial Infarction

Time frame
60 months
4

Revascularization due to ischemia

Ischemia driven revascularization, including repeated PCI or CABG due to recurrent or persistent ischemic symptoms

Time frame
60 months

Other outcomes

Sponsors and contacts

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