Biomarkers in Acute Cardiac Care

Обзор

The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

Подробное описание

The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction.

Secondary study aims are :

* To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain; * To provide accurate, quantifiable measures of precursors of ACS; * DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies * To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach; * To explore proteins relevant for ACS; * To allow the identification of new therapeutic targets; * To evaluate the impact of socio-economic factors on ACS and CAD risk.

Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.

Первичные конечные точки

• Acute myocardial infarction as index event [Срок оценки: Months]

Вторичные конечные точки (1)

• AMI, Mortality, heart failure and quality of life [Срок оценки: Years]

Критерии участия

Критерии включения

• Symptoms suggestive of acute myocardial infarction
• Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
• Individuals at least 18 years old

Критерии исключения

\- Insufficient knowledge of the German language (able to understand and write the German language)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Department of Cardiology, University Heart Center Hamburg — Hamburg

Публикации

• Neumann JT, Sorensen NA, Schwemer T, Ojeda F, Bourry R, Sciacca V, Schaefer S, Waldeyer C, Sinning C, Renne T, Than M, Parsonage W, Wildi K, Makarova N, Schnabel RB, Landmesser U, Mueller C, Cullen L, Greenslade J, Zeller T, Blankenberg S, Karakas M, Westermann D. Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I 1-Hour Algorithm. JAMA Cardiol. 2016 Jul 1;1(4):397-404. doi: 10 PMID 27438315
• Neumann JT, Sorensen NA, Ojeda F, Schwemer T, Lehmacher J, Gonner S, Jarsetz N, Keller T, Schaefer S, Renne T, Landmesser U, Clemmensen P, Makarova N, Schnabel RB, Zeller T, Karakas M, Pickering JW, Than M, Parsonage W, Greenslade J, Cullen L, Westermann D, Blankenberg S. Immediate Rule-Out of Acute Myocardial Infarction Using Electrocardiogram and Baseline High-Sensitivity Troponin I. Clin Chem. PMID 27903616
• Volschow B, Strauss B, Sorensen NA, Thiessen N, Lehmacher J, Toprak B, Abdennadher B, Dehkordi F, Haller PM, Scharlemann L, Schock A, Petersmann A, Gauss F, Twerenbold R, Neumann JT. Diagnostic validation of a novel high-sensitivity cardiac troponin T assay. Eur Heart J Acute Cardiovasc Care. 2026 Jul 8;15(7):535-544. doi: 10.1093/ehjacc/zuag044. PMID 42008514
• Glaeser J, Lopez-Ayala P, Kellner C, Boeddinghaus J, Nestelberger T, Koechlin L, Sorensen NA, Haller PM, Bima P, Crisanti L, Spagnuolo CC, Strebel I, Hure G, Sieber S, Rubini Gimenez M, Wildi K, Wussler D, Miro O, Martin-Sanchez FJ, Keller DI, Christ M, Twerenbold R, Mahfoud F, Neumann J, Mueller C; APACE and BACC Investigators. Comparison of the European Society of Cardiology 0/1-Hour and High-Se PMID 41706062
• Haller PM, Schock A, Kellner C, Lehmacher J, Toprak B, Hartikainen TS, Kiss KM, Alhaou G, Peifer K, Twerenbold R, Zeller T, Westermann D, Neumann JT, Sorensen NA. Bedside echocardiography in patients with suspected acute myocardial infarction without ST elevation. Clin Res Cardiol. 2025 Aug 19. doi: 10.1007/s00392-025-02724-2. Online ahead of print. PMID 40828180
• Thiebetaen N, Pickering JW, Kellner C, Haller PM, Lehmacher J, Toprak B, Twerenbold R, Sorensen NA, Pemberton C, Troughton R, Richards AM, Sharif S, Worster A, Than M, Kavsak PA, Neumann JT. A Common Algorithm for Cardiac Troponin to Rule Out and Rule in Acute Myocardial Infarction. Can J Cardiol. 2025 Jul;41(7):1351-1360. doi: 10.1016/j.cjca.2025.02.029. Epub 2025 Feb 26. PMID 40021054
• Haller PM, Kellner C, Sorensen NA, Lehmacher J, Toprak B, Schock A, Hartikainen TS, Twerenbold R, Zeller T, Westermann D, Neumann JT. Long-term outcome of patients presenting with myocardial injury or myocardial infarction. Clin Res Cardiol. 2025 Jun;114(6):700-708. doi: 10.1007/s00392-023-02334-w. Epub 2023 Nov 20. PMID 37982865
• Haller PM, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Toprak B, Twerenbold R, Richter J, Banko T, Korschid S, Schmidt J, Keller T, Zeller T, Blankenberg S, Westermann D, Neumann JT. Rising and Falling High-Sensitivity Cardiac Troponin in Diagnostic Algorithms for Patients With Suspected Myocardial Infarction. J Am Heart Assoc. 2023 May 16;12(10):e027166. doi: 10.1161/JAHA.122.027166. Ep PMID 37158171

Идентификаторы

NCT: NCT02355457 · PV4306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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