Impact of Inflammation on Heart Procedure Outcomes
A Prospective Study of Residual Inflammatory Risk and the Impact on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Interventions
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT05131750
This study is testing how inflammation levels in patients with coronary artery disease affect their recovery and heart health after a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1408 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05131750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of residual inflammation risk (RIR) in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI). It will measure high-sensitivity C-reactive protein (hsCRP) levels before and after the procedure to assess their impact on major adverse cardiovascular events (MACE). The study will recruit hospitalized patients, monitoring changes in hsCRP over time to better understand its correlation with patient outcomes. The findings could help define RIR values specific to the Chinese population undergoing PCI.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 to 80 with coronary heart disease who are undergoing PCI.
Not a fit: Patients with uncontrolled infections, autoimmune diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for patients with CAD undergoing PCI.
How similar studies have performed: While the concept of RIR has been explored in other populations, this specific investigation in the Chinese context is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants who understand and sign the informed consent form voluntarily; 2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex; 3. The hospitalized patients with coronary heart disease undergoing PCI; 4. Complete all planned PCI during hospitalization Exclusion Criteria: 1. Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease; 2. Uncontrolled infectious diseases during the screening period; 3. 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; 4. Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period; 5. Surgical or interventional treatment was performed within 3 months before the screening period; 6. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives; 7. Participated in other clinical trials within 3 months before the screening period; 8. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Where this trial is running
Wuhan, Hubei
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Miao Yu, Doctor
- Email: yumiaodavid@126.com
- Phone: +8613995562434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: hsCRP