NCT05131750 RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI
| NCT ID | NCT05131750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | hsCRP |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,408 participants |
| Start Date | 2021-05-06 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,408 participants in total. It began in 2021-05-06 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05131750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying hsCRP. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05131750 currently recruiting?
Yes, NCT05131750 is actively recruiting participants. Contact the research team at yumiaodavid@126.com for enrollment information.
Where is the NCT05131750 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05131750 clinical trial?
NCT05131750 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 1,408 participants.