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Набор скоро начнётся NCT07515807

Qatar Cardiometabolic Retrospective Cohort-Analysis Using Artificial Intelligence

— Наблюдательное Cardio Vascular Disease Acute Coronary Syndromes (ACS) Type 2 Diabetes Pre Diabetes

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: Cardio Vascular Disease, Acute Coronary Syndromes (ACS), Type 2 Diabetes, Pre Diabetes. 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
Катар
Следующий шаг
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Обзор

Cardiovascular disease is the leading cause of death worldwide, and individuals with diabetes or other cardiometabolic conditions are at increased risk of adverse cardiovascular outcomes. Although advances in prevention and treatment have reduced cardiovascular events globally, cardiometabolic disease continues to represent a significant health burden, particularly in regions with high diabetes prevalence. In Qatar and other Gulf Cooperation Council countries, the prevalence of diabetes and obesity is increasing, contributing to a high proportion of participants presenting with acute coronary syndrome who have type 2 diabetes or prediabetes. This observational study will use electronic medical record data from patients hospitalized at the Heart Hospital with acute coronary syndrome and a concomitant diagnosis of diabetes or prediabetes. The study will assess trends in cardiovascular risk factors and cardiovascular events, including readmission and mortality. An artificial intelligence component will be used to develop and validate machine learning based risk prediction models to forecast adverse cardiovascular outcomes in participants with cardiometabolic disease. These models will integrate clinical, biochemical, imaging, and other non-invasive data routinely collected during participants care to identify predictors of cardiovascular events.

Подробное описание

This study combines retrospective and prospective designs.

Retrospective:

We use past electronic medical records to identify participants and collect baseline information from their initial visit (using their code or health card number).

Prospective:

From that starting point, we follow the same participants forward in time, updating data every two years and recording new outcomes (mortality, cardiovascular events, rehospitalizations, treatment-related outcomes) at planned checkpoints (approximately 6 months, 1 year, and 2 years).

New eligible participants identified in later data extractions are added and followed in the same manner. Because we only observe and record participants existing records and outcomes without assigning interventions, the study is observational.

Первичные конечные точки

  • Incidence of 3-point Major Adverse Cardiovascular Events (MACE) in Acute Coronary Syndrome Patients [Срок оценки: 5 years]
  • Incidences of 2-point Major Adverse Cardiovascular Events (MACE) in Heart Failure Patients [Срок оценки: 5 years]
Вторичные конечные точки (9)
  • Major Adverse Cardiovascular Events [Срок оценки: 5 years]
  • Unstable angina requiring hospitalization [Срок оценки: 5 years]
  • Arrhythmic events [Срок оценки: 5 years]
  • Coronary revascularization [Срок оценки: 5 years]
  • Post-Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) complications (stent/graft thrombosis or repeat revascularization) [Срок оценки: 5 years]
  • Development or progression of valvular heart disease (aortic or mitral stenosis/regurgitation) [Срок оценки: 5 years]
  • New-onset diabetes mellitus [Срок оценки: 5 years]
  • Change in glycated Hemoglobin A1c (HbA1c) [Срок оценки: 5 years]
  • Newly diagnosed medical or surgical conditions not present at baseline [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Age ≥ 18
  • Qatari and Arab participants
  • Participants admitted for Acute Coronary Syndrome (ACS) or Acute Heart Failure (AHF)
  • Metabolic disease: Diabetes (HbA1C ≥ 6.5% or any HbA1C if a patient is on an antidiabetic agent) or pre-diabetes: 5.7% ≤ HbA1c ≤ 6.4%

Критерии исключения

  • Non-Qatari or non-Arab participants
  • Non-diabetic: HbA1C < 5.7%
  • This chart review involves no direct interaction with individuals. Prisoners are not a focus of this study, and incarceration status is not identifiable in the records reviewed.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Катар · 1 центр
  • Hamad Medical Corporation — Doha

Идентификаторы

NCT: NCT07515807 · 25-00019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗