Clinical trial NCT05614050: HsCRP in the Prognosis of Patients After PCI：a Multi-center Study
Official title: High-sensitivity C-reactive Protein (hsCRP) in the Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: hsCRP
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital of Xiamen University
name: Shanxi Cardiovascular Hospital
name: First People's Hospital of Xianyang
name: Yichang Central People's Hospital
name: Jingzhou Central Hospital
name: The First Hospital of Wuhan
name: Wuhan Central Hospital
name: Wuhan Fourth Hospital
name: Fifth Hospital in Wuhan
name: Wuhan Union Hospital West Campus
name: Wuhan Union Hospital Jinyinhu Campus
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Wuhan Asia Heart Hospital
name: Tianjin Medical University General Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
name: Hubei University of Medicine
name: The Third Xiangya Hospital of Central South University
First posted: 2022-11-14
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The hospitalized patients with coronary heart disease completing all planned PCI

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MACCE
timeFrame: 12 months
Secondary outcomes:
measure: all-cause death
timeFrame: 12 months
measure: cardiovascular death
timeFrame: 12 months
measure: nonfatal myocardial infarction
timeFrame: 12 months
measure: nonfatal stroke
timeFrame: 12 months
measure: ischemia-driven revascularization
timeFrame: 12 months
measure: hospitalization for unstable angina
timeFrame: 12 months
measure: stent/scaffold thrombosis
timeFrame: 12 months
measure: in-stent restenosis
timeFrame: 12 months
measure: bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Xiang Cheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: