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NCT Number: NCT05614050

The Prognosis of Patients After PCI：a Multi-center 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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location status: Recruiting

Location contact

Xiang Cheng, Doctor

CONTACT

[email protected]

+8602785726011

Xiang Cheng, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. MACCE

    Time frame: 12 months

    A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

Secondary outcomes

  1. all-cause death

    Time frame: 12 months

    Occurrence of all-cause death

  2. cardiovascular death

    Time frame: 12 months

    Occurrence of cardiovascular death

  3. nonfatal myocardial infarction

    Time frame: 12 months

    Occurrence of nonfatal myocardial infarction

  4. nonfatal stroke

    Time frame: 12 months

    Occurrence of of nonfatal stroke

  5. ischemia-driven revascularization

    Time frame: 12 months

    Occurrence of ischemia-driven revascularization

  6. hospitalization for unstable angina

    Time frame: 12 months

    Occurrence of hospitalization for unstable angina

  7. stent/scaffold thrombosis

    Time frame: 12 months

    Occurrence of stent/scaffold thrombosis

  8. in-stent restenosis

    Time frame: 12 months

    Occurrence of in-stent restenosis

  9. bleeding

    Time frame: 12 months

    Occurrence of bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Miao Yu

CONTACT

[email protected]

+862785726009

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Fifth Hospital in Wuhan
  • First People's Hospital of Xianyang
  • Hubei University of Medicine
  • Jingzhou Central Hospital
  • Shandong Provincial Hospital
  • Shanxi Cardiovascular Hospital
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Xiamen University
  • The First Affiliated Hospital of Zhengzhou University
  • The First Hospital of Wuhan
  • Wuhan Asia Heart Hospital
  • Wuhan Central Hospital
  • Wuhan Fourth Hospital
  • Yichang Central People's Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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