HsCRP in the Prognosis of Patients After PCI：a Multi-center Study

Recruiting

• Conditions: hsCRP

• Registration Number: NCT05614050
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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 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 on MACCE in PCI population remains unclear. Therefore, in this study, the investigators 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 1 years at 14 hospitals in China.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACCE	12 months	A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

Secondary Outcome Measures

Name	Time	Method
cardiovascular death	12 months	Occurrence of cardiovascular death
nonfatal stroke	12 months	Occurrence of of nonfatal stroke
ischemia-driven revascularization	12 months	Occurrence of ischemia-driven revascularization
in-stent restenosis	12 months	Occurrence of in-stent restenosis
nonfatal myocardial infarction	12 months	Occurrence of nonfatal myocardial infarction
bleeding	12 months	Occurrence of bleeding
all-cause death	12 months	Occurrence of all-cause death
hospitalization for unstable angina	12 months	Occurrence of hospitalization for unstable angina
stent/scaffold thrombosis	12 months	Occurrence of stent/scaffold thrombosis

Trial Locations

Locations (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China