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NCT Number: NCT05131750

RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

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.

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Key information

Conditions

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

About this study

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

Who can participate

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

Inclusion criteria

  • Participants who understand and sign the informed consent form 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

  • Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease;
  • Uncontrolled infectious diseases during the screening period;
  • 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;
  • Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period;
  • Surgical or interventional treatment was performed within 3 months before the screening period;
  • Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
  • Participated in other clinical trials within 3 months before the screening period;
  • 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. Major adverse cardiovascular events (MACEs)

    Time frame: 60 months

    Composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and revascularization due to ischemia

Secondary outcomes

  1. All-cause death

    Time frame: 60 months

    Death due to any cause

  2. Cardiovascular death

    Time frame: 60 months

    Death due to cardiovascular cause

  3. Nonfatal myocardial infarction

    Time frame: 60 months

    According to the fourth edition of the General Definition of Myocardial Infarction

  4. Revascularization due to ischemia

    Time frame: 60 months

    Ischemia driven revascularization, including repeated PCI or CABG due to recurrent or persistent ischemic symptoms

  5. In-stent thrombosis

    Time frame: 60 months

    In-stent thrombosis is determined based on the degree of certainty and the time after PCI

  6. Nonfatal stroke

    Time frame: 60 months

    Acute neurological deficits caused by pathological basis of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and cerebral venous sinus thrombosis affecting brain tissue

  7. Bleeding

    Time frame: 60 months

    According to the report from the Bleeding Academic Research Consortium

Study contacts

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

Miao Yu, Doctor

CONTACT

[email protected]

+8613995562434

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

A Prospective Study of Residual Inflammatory Risk and the Impact on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Interventions

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2021
Registry last updated
Dec 22, 2023

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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