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Идёт набор NCT05131750

RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

— Наблюдательное hsCRP

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: hsCRP. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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

Первичные конечные точки

  • Major adverse cardiovascular events (MACEs) [Срок оценки: 60 months]
Вторичные конечные точки (7)
  • All-cause death [Срок оценки: 60 months]
  • Cardiovascular death [Срок оценки: 60 months]
  • Nonfatal myocardial infarction [Срок оценки: 60 months]
  • Revascularization due to ischemia [Срок оценки: 60 months]
  • In-stent thrombosis [Срок оценки: 60 months]
  • Nonfatal stroke [Срок оценки: 60 months]
  • Bleeding [Срок оценки: 60 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of S — Ухань

Публикации

  • 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 D PMID 28845751
  • 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
  • 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

Идентификаторы

NCT: NCT05131750 · RIR-PCI

Первоисточники (государственные реестры)

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