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Набор скоро начнётся NCT07426107

Development and Prospective Validation of an AI Model for Prognosis in ITP Patients Undergoing Coronary Revascularization

— Наблюдательное Immune Thrombocytopenic Purpura Coronary Artery Disease

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: Immune Thrombocytopenic Purpura, Coronary Artery Disease. Базовые параметры: 18 лет — 90 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
Список центров уточняется — проверьте первичный протокол.
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

An Artificial Intelligence-Enhanced Longitudinal Cohort Study to Optimize Revascularization Decisions in Patients With Coronary Artery Disease and Immune Thrombocytopenia (The ITP-CAD AI-REVASC Study)

Обзор

This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development/training cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.

Подробное описание

Study Design: This is a dual-phase, multi-center observational study. Phase 1 (Retrospective Cohort): A retrospective cohort will serve as the development and training set. Data from eligible patients treated in the past will be collected to identify predictors and develop the initial AI prediction model.

Phase 2 (Prospective Cohort): A prospective, observational cohort will serve as the validation set. Consecutively eligible patients will be enrolled and followed forward in time. The model derived from Phase 1 will be applied to this cohort to evaluate its predictive accuracy and clinical utility.

Treatment Groups: Within both cohorts, patients will be categorized based on actual clinical care:

1. Revascularization Group: Patients undergoing PCI or CABG. 2. Medical Therapy Group: Patients managed with guideline-directed medical therapy alone.

Objective: To compare MACE risk between groups and to develop and validate a model predicting MACE specifically in the revascularization group.

Первичные конечные точки

  • 1-month incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: from the date of CAD diagnosis (index date) until 1 month of follow-up]
  • 1-year incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: from the date of CAD diagnosis (index date) until 1 year of follow-up]
Вторичные конечные точки (5)
  • key predictors of adverse outcomes following revascularization [Срок оценки: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up]
  • BARC type ≥2 bleeding event [Срок оценки: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up]
  • overall bleeding event [Срок оценки: from the date of CAD diagnosis (index date) until 1 month and 1 year of follow-up]
  • Hospitalization for CAD within 1 year. [Срок оценки: from the date of CAD diagnosis (index date) until 1 year of follow-up]
  • 1-year overall survival [Срок оценки: from the date of CAD diagnosis (index date) until 1 year of follow-up]

Критерии участия

Критерии включения

  • Age ≥ 18 years.
  • Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.
  • Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.
  • The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.
  • Capable of providing informed consent (for prospective enrollment and data collection).

Критерии исключения

  • Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).
  • Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).
  • Life expectancy less than 1 year due to non-cardiovascular disease.
  • Inability to comply with follow-up.
  • Inability to give informed consent.
  • Pregnancy or breastfeeding.
  • A history of Type 2 Myocardial Infarction prior to the index treatment decision.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07426107 · The ITP-CAD AI-REVASC Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗