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Идёт набор NCT06128317

Myocardial Infarction Registry

Наблюдательное Acute Coronary Syndrome

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
В протоколе указаны: no intervention is intended..
Кому может быть актуально
Состояния в реестре: Acute Coronary Syndrome. 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Cardiac Biochemical and Omics-based Biomarkers in Patients Presenting Symptoms of Acute Coronary Syndrome in the Emergency Department (ACS Registry)

Обзор

The single-center MIR-registry was created to assess real-world prevalence, demographic characteristics and management of patients with acute coronary syndrome presenting in the emergency department (ED) of University of Heidelberg.

Подробное описание

To conduct a comprehensive characterization of patients with symptoms of acute coronary syndrome or elevated troponin levels. Records include clinical routine parameters, there will be an expansion involving the collection of blood samples for the analysis of novel laboratory-based and omics-based biomarkers. The ACS registry is monothetically managed by the Department of Internal Medicine III at Heidelberg University Hospital and is intended to serve as a basis for further clinical diagnostic and outcome studies. The blood samples will serve as the foundation for a comprehensive analysis of established and novel laboratory-based markers, as well as omics-based biomarkers (miRNA, metabolomics, and proteomics). Follow-up was performed via review of medical reports, phone calls and postal queries. The outcome parameters comprised rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction, and hospitalization for any cause.

Вмешательства

  • Другое no intervention is intended.
    no intervention is intended.

Первичные конечные точки

  • all-cause mortality [Срок оценки: 12 months]
Вторичные конечные точки (3)
  • myocardial infarction [Срок оценки: 12 months]
  • stroke [Срок оценки: 12 months]
  • Rehospitalization [Срок оценки: 12 months]

Критерии участия

Критерии включения

The study will include consecutive patients who present to the cardiology emergency department at Heidelberg University Hospital with symptoms of acute coronary syndrome or a troponin increase (hs-TnT >14 ng/L). Additional inclusion criteria are a minimum age of 18 years and providing informed consent through written consent to participate in the study. The following medical conditions are intended to be distinguished from one another:

  • Acute myocardial infarction
  • Unstable angina pectoris
  • Myocarditis
  • Heart failure
  • Cardiomyopathies
  • Pulmonary embolism
  • Renal insufficiency
  • Supraventricular and ventricular tachycardias
  • Hypertensive crisis
  • Non-cardiac chest pain

Критерии исключения

Exclusion criteria are defined according to GCP (Good Clinical Practice), i.e., mental illnesses/dementia (lack of capacity to provide informed consent), pregnancy/breastfeeding, as well as acute conditions requiring immediate treatment (e.g., cardiogenic shock).

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • University Hospital of Heidelberg — Heidelberg

Публикации

  • Yildirim M, Salbach C, Mueller-Hennessen M, Frey N, Giannitsis E. Comparative Analysis of Single- and Dual-Marker Strategies for Rapid Non-ST-Segment-Elevation Myocardial Infarction Rule-Out Using Cardiac Myosin-Binding Protein C, Copeptin, and High-Sensitivity Cardiac Troponin T in the Emergency Department. J Am Heart Assoc. 2025 May 20;14(10):e039379. doi: 10.1161/JAHA.124.039379. Epub 2025 May PMID 40357668
  • Yildirim M, Salbach C, Reich C, Milles BR, Biener M, Frey N, Giannitsis E, Mueller-Hennessen M. Comparison of the clinical chemistry score to other biomarker algorithms for rapid rule-out of acute myocardial infarction and risk stratification in patients with suspected acute coronary syndrome. Int J Cardiol. 2024 Apr 1;400:131815. doi: 10.1016/j.ijcard.2024.131815. Epub 2024 Jan 24. PMID 38278492

Идентификаторы

NCT: NCT06128317 · MIR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗