RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

NCT05131750 | Recruiting

• 1 other identifier: RIR-PCI
• Study Type: observational
• Target: 1,408
• Locations: 1 country
• Sites: 1

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.

Conditions

hsCRP

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACEs)

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

  60 months

Secondary Outcomes (7)

• All-cause death

  60 months

• Cardiovascular death

  60 months

• Nonfatal myocardial infarction

  60 months

• Revascularization due to ischemia

  60 months

• In-stent thrombosis

  60 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary heart disease completed all planned PCI during hospitalization

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (3)

• Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease. N Engl J Med. 2017 Sep 21;377(12):1119-1131. doi: 10.1056/NEJMoa1707914. Epub 2017 Aug 27.

  PMID: 28845751 RESULT

• Kalkman DN, Aquino M, Claessen BE, Baber U, Guedeney P, Sorrentino S, Vogel B, de Winter RJ, Sweeny J, Kovacic JC, Shah S, Vijay P, Barman N, Kini A, Sharma S, Dangas GD, Mehran R. Residual inflammatory risk and the impact on clinical outcomes in patients after percutaneous coronary interventions. Eur Heart J. 2018 Dec 7;39(46):4101-4108. doi: 10.1093/eurheartj/ehy633.

  PMID: 30358832 RESULT

• Ridker PM. Residual inflammatory risk: addressing the obverse side of the atherosclerosis prevention coin. Eur Heart J. 2016 Jun 7;37(22):1720-2. doi: 10.1093/eurheartj/ehw024. Epub 2016 Feb 22. No abstract available.

  PMID: 26908943 RESULT

Central Study Contacts

Miao Yu, Doctor

CONTACT

+8613995562434; yumiaodavid@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of cardiology, Wuhan Union Hospital, China

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: November 23, 2021
• Study Start: May 6, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

CN (1)