RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

Recruiting

• Conditions: hsCRP

• Registration Number: NCT05131750
• 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 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.

Detailed Description

Serial hsCRP measurements with ≥ 4 weeks between both measurements are defined in this analysis. Time-to-event is measured from first hsCRP measurement.

Study Timeline

• Study First Submitted: 2021-05-03
• Study Start: 2021-05-06
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1408

Inclusion Criteria

1. Participants who understand and sign the informed consent form voluntarily;
2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
3. The hospitalized patients with coronary heart disease undergoing PCI;
4. Complete all planned PCI during hospitalization

Exclusion Criteria

1. Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease;
2. Uncontrolled infectious diseases during the screening period;
3. 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;
4. Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period;
5. Surgical or interventional treatment was performed within 3 months before the screening period;
6. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
7. Participated in other clinical trials within 3 months before the screening period;
8. 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
Major adverse cardiovascular events (MACEs)	60 months	Composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and revascularization due to ischemia

Secondary Outcome Measures

Name	Time	Method
Nonfatal myocardial infarction	60 months	According to the fourth edition of the General Definition of Myocardial Infarction
Revascularization due to ischemia	60 months	Ischemia driven revascularization, including repeated PCI or CABG due to recurrent or persistent ischemic symptoms
In-stent thrombosis	60 months	In-stent thrombosis is determined based on the degree of certainty and the time after PCI
Nonfatal stroke	60 months	Acute neurological deficits caused by pathological basis of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and cerebral venous sinus thrombosis affecting brain tissue
Bleeding	60 months	According to the report from the Bleeding Academic Research Consortium
Cardiovascular death	60 months	Death due to cardiovascular cause
All-cause death	60 months	Death due to any cause

Trial Locations

Locations (1)

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