Меню
Идёт набор NCT07523880

Multi-Omics-Based Novel Thrombosis and Bleeding Markers and Risk Model for CHD

— Наблюдательное Thrombosis Bleeding Coronary Artery Disease (CAD)

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: Thrombosis, Bleeding, Coronary Artery Disease (CAD). Базовые параметры: от 18 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Multi-Omics-Based Development of Novel Thrombosis and Bleeding Markers and Construction of a Risk Prediction Model in Coronary Heart Disease

Обзор

Patients with coronary heart disease who take dual antiplatelet therapy face two serious risks: thrombosis and major bleeding. This study aims to develop better ways to predict these risks and guide personalized treatment. The investigators will use a large, long-term follow-up study of Chinese patients with coronary heart disease. This research plans to discover new biomarkers related to clot and bleeding risk. The study will combine information from proteins, metabolites, sugars attached to proteins, genes, and medical images. Using machine learning methods, the investigators will identify the most important markers and test them in the patient group of this study. The investigators will then build new risk prediction models that include these new markers together with traditional risk scores (such as GRACE, PARIS, and Precise-DAPT). This study will check whether these new models are better than existing ones at predicting who will develop clots or bleeding and at helping doctors decide on the best treatment for each patient. The new aspects of this research are: (1) using advanced multi-omics technology to find novel markers specifically for Chinese patients; (2) combining clinical, biological, and imaging data to improve prediction accuracy; and (3) using machine learning to create more precise risk models. The goal is to provide doctors with a more accurate tool to assess each patient's risk of clots and bleeding. This will help them choose the safest and most effective antiplatelet treatment, reduce serious complications, and improve patient care.

Первичные конечные точки

  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Срок оценки: Up to 24 months after enrollment]
  • Major Bleeding Events [Срок оценки: Up to 24 months after enrollment]
Вторичные конечные точки (4)
  • All-Cause Death [Срок оценки: Up to 24 months after enrollment]
  • Myocardial Infarction [Срок оценки: Up to 24 months after enrollment]
  • Stroke [Срок оценки: Up to 24 months after enrollment]
  • Stent Thrombosis [Срок оценки: Up to 24 months after enrollment]

Критерии участия

Критерии включения

  • Age ≥ 18 years.
  • Hospitalized due to symptoms or objective evidence of coronary heart disease and planned for long-term antithrombotic therapy.
  • Diagnosis of acute coronary syndrome or stable coronary heart disease undergoing percutaneous coronary intervention (PCI), with clinical stability meeting discharge criteria after treatment.
  • For patients from the existing cohort: minimum 2 years of follow-up with complete clinical data and blood specimens available; approval for use of these data and specimens has been obtained, with a waiver of re-consent.

For newly enrolled patients: voluntary written informed consent provided by the patient or legal representative, agreement to provide blood samples, and acceptance of follow-up procedures.

Критерии исключения

For patients from the existing cohort:

  • Severe missing or erroneous baseline or clinical data that cannot be corrected by source verification.
  • No available blood specimen, or specimen that does not meet testing requirements.

For newly enrolled patients:

  • Presence of serious comorbid conditions with life expectancy ≤ 6 months.
  • Conditions that significantly affect study compliance or the ability to complete follow-up.
  • Contraindications to blood sampling.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 3 центра
  • Fuwai Central China Cardiovascular Hospital — Чжэнчжоу
  • General Hospital of Northern Theater Command of Chinese People's Liberation Army — Шэньян
  • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Пекин

Идентификаторы

NCT: NCT07523880 · 2025ZD0546401

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗