Actively Recruiting

Age: 18Years - 80Years
All Genders
ID05131750

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

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2023-12-22

1408

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Coronary heart disease (CAD) results from reduced blood flow to the heart due to narrowed or blocked coronary arteries. This condition can cause heart muscle damage from lack of oxygen. Despite effective drug treatments after percutaneous coronary interventions (PCI), patients with CAD remain at high risk for major adverse cardiovascular events (MACE). This study focuses on residual inflammation risk (RIR), an important factor linked to worse outcomes in CAD. The study aims to define the RIR standard in Chinese patients undergoing PCI and explore how changes in high-sensitivity C-reactive protein (hsCRP) levels affect MACE over a 5-year period. Participants in this observational study will have serial hsCRP blood tests at least 4 weeks apart, starting with the first measurement after PCI. The study will track patients over 60 months to observe the impact of RIR on their cardiovascular health. No treatments or interventions are assigned; instead, researchers will monitor natural changes in inflammation markers and clinical outcomes. During the study, participants will undergo regular laboratory testing to measure hsCRP and other key health indicators. Researchers will record major cardiovascular events such as heart attacks, strokes, deaths, and bleeding episodes. Participants’ clinical progress will be followed for five years to assess long-term outcomes related to inflammation and heart disease. This comprehensive monitoring aims to improve understanding of inflammation’s role in CAD prognosis after PCI.

CONDITIONS

Brief Title

RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who understand and voluntarily sign the informed consent form
  • Age 18 years or older and 80 years or younger, any sex
  • Hospitalized patients with coronary heart disease undergoing PCI
  • Completion of all planned PCI procedures during hospitalization
Not Eligible

You will not qualify if you...

  • Patients not receiving standard guideline-based treatment for coronary heart disease
  • Uncontrolled infections during screening
  • Presence of immune or immune-related diseases such as lupus, asthma, inflammatory bowel disease, gout, or cancer
  • Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory, or chemotherapy drugs
  • Surgical or interventional treatments within 3 months before screening
  • Pregnant or breastfeeding women, or women of childbearing age not using effective contraception
  • Participation in other clinical trials within 3 months before screening
  • Any other condition deemed unsuitable for trial participation by researchers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 60 months

Participants undergo serial blood tests to measure inflammation markers with at least 4 weeks between measurements while their clinical outcomes are observed.

Trial Site Locations

Total: 1 location

1

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

Wuhan, Hubei, China, 430022

Actively Recruiting

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Research Team

M

Miao Yu, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial

Residual inflammatory risk and the impact on clinical outcomes in patients after percutaneous coronary interventions.

Deborah N Kalkman, Melissa Aquino, Bimmer E Claessen...

https://pubmed.ncbi.nlm.nih.gov/30358832