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

The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China

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 Overview

• Status: Recruiting
• Conditions: Inflammation

• Study Type: Observational
• Enrollment (Estimated): 2400

Contacts and Locations

• Study Contact: Name: Miao Yu; Phone Number: +862785726009; Email: yumiaodavid@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Cheng, Doctor; Phone Number: +8602785726011; Email: nathancx@hust.edu.cn
      • Principal Investigator: Xiang Cheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The hospitalized patients with coronary heart disease completing all planned PCI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Shandong Provincial Hospital; The First Affiliated Hospital of Zhengzhou University; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Yichang Central People's Hospital; Wuhan Central Hospital; The First Affiliated Hospital of Xiamen University; Shanxi Cardiovascular Hospital; First People's Hospital of Xianyang; Jingzhou Central Hospital; The First Hospital of Wuhan; Wuhan Fourth Hospital; Fifth Hospital in Wuhan; Central Hospital of Enshi Tujia and Miao Autonomous Prefecture; Hubei University of Medicine
• Investigators: Principal Investigator: Xiang Cheng, Doctor, Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 22, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: ChiPCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No