RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: hsCRP

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1408

Contacts and Locations

• Study Contact: Name: Miao Yu, Doctor; Phone Number: +8613995562434; Email: yumiaodavid@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Cheng, Doctor; Phone Number: +8602785726011; Email: nathancx@hust.edu.cn
      • Principal Investigator: Xiang Cheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with coronary heart disease completed all planned PCI during hospitalization

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events (MACEs)	Composite endpoint of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and revascularization due to ischemia	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Death due to any cause	60 months
Cardiovascular death	Death due to cardiovascular cause	60 months
Nonfatal myocardial infarction	According to the fourth edition of the General Definition of Myocardial Infarction	60 months
Revascularization due to ischemia	Ischemia driven revascularization, including repeated PCI or CABG due to recurrent or persistent ischemic symptoms	60 months
In-stent thrombosis	In-stent thrombosis is determined based on the degree of certainty and the time after PCI	60 months
Nonfatal stroke	Acute neurological deficits caused by pathological basis of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, and cerebral venous sinus thrombosis affecting brain tissue	60 months
Bleeding	According to the report from the Bleeding Academic Research Consortium	60 months

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RIR-PCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No