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Recruiting NCT05614050

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

— Observational Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inflammation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Primary outcome measures

  • MACCE [Time frame: 12 months]
Secondary outcome measures (9)
  • all-cause death [Time frame: 12 months]
  • cardiovascular death [Time frame: 12 months]
  • nonfatal myocardial infarction [Time frame: 12 months]
  • nonfatal stroke [Time frame: 12 months]
  • ischemia-driven revascularization [Time frame: 12 months]
  • hospitalization for unstable angina [Time frame: 12 months]
  • stent/scaffold thrombosis [Time frame: 12 months]
  • in-stent restenosis [Time frame: 12 months]
  • bleeding [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of S — Wuhan

Identifiers

NCT: NCT05614050 · ChiPCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗