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RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

NCT ID: NCT05131750

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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hsCRP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Xiang Cheng

Head of department of cardiology, Wuhan Union Hospital, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Miao Yu, Doctor

Role: CONTACT

Phone: +8613995562434

Email: [email protected]

Facility Contacts

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Xiang Cheng, Doctor

Role: primary

References

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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.

Reference Type RESULT
PMID: 28845751 (View on PubMed)

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.

Reference Type RESULT
PMID: 30358832 (View on PubMed)

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.

Reference Type RESULT
PMID: 26908943 (View on PubMed)

Other Identifiers

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RIR-PCI

Identifier Type: -

Identifier Source: org_study_id