The Prognosis of Patients After PCI：a Multi-center Study in China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology2,400 enrolled

Overview

Coronary artery 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 and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP and other inflammatory factors on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of hsCRP and other inflammatory factors on the prognosis of these patients during long term follow-up at 17 hospitals in China.

Study Type

OBSERVATIONAL

Enrollment

2,400

Conditions

Inflammation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who understand and sign the informed consent 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. Exclusion Criteria: * Acute, chronic or recurrent infectious diseases; * Immune diseases or immune-related diseases; * Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs; * Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures; * The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.

Outcomes

Primary Outcomes

MACCE

A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

Time frame: 12 months

Secondary Outcomes

all-cause death

Occurrence of all-cause death

Time frame: 12 months

cardiovascular death

Occurrence of cardiovascular death

Time frame: 12 months

nonfatal myocardial infarction

Occurrence of nonfatal myocardial infarction

Time frame: 12 months

nonfatal stroke

Occurrence of of nonfatal stroke

Time frame: 12 months

ischemia-driven revascularization

Occurrence of ischemia-driven revascularization

Time frame: 12 months

hospitalization for unstable angina

Occurrence of hospitalization for unstable angina

Time frame: 12 months

stent/scaffold thrombosis

Occurrence of stent/scaffold thrombosis

Time frame: 12 months

in-stent restenosis

Occurrence of in-stent restenosis

Time frame: 12 months

bleeding

Occurrence of bleeding

Time frame: 12 months

The Prognosis of Patients After PCI：a Multi-center Study in China

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts