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临床试验/NCT06295978
NCT06295978招募中不适用

Prognostic Value of Cardiovascular Risk of sST2, suPAR and High-sensitivity Troponin I in Patients With Acute Chest Pain

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
The predictive value of markers for the risk of cardiovascular events in chest pain

研究概览

简要总结

Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.

The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation.

详细描述

BACKGROUND: Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.

The role of the biomarker sST2 has been widely explored in heart failure, so much so that it was included in the AHA guidelines in 2013 and 2017. Recently, several studies are also proposing a role of sST2 in the prognostic stratification of patients with Acute Coronary Syndrome and ischaemic heart disease, in association with other biomarkers even proposing a possible therapeutic differentiation.

Furthermore, current studies have explored the role of the suPAR biomarker in cardiovascular disease. Indeed, its serum levels, closely correlated with immune and inflammatory activation, reveal it as a promising prognostic indicator. Although its non-cardiac-specific nature limits its diagnostic value for heart disease, its added value in identifying patients at risk of adverse cardiovascular events, morbidity and mortality when used in a multi-marker approach has been highlighted.

The combined use of sST2 and suPAR with high-sensitivity troponins, as opposed to contemporary troponins, exploring complementary aspects of myocardial damage, could be a promising strategy to identify those patients who, although with early rule-out after evaluation in the emergency room, present a higher risk of occurrence of distant cardiovascular events, thus deserving to be subjected to a customised diagnostic-instrumental procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years;
  • Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis
  • ECG not diagnostic for ischemia
  • cTnI ultra within limits

排除标准

  • Sepsis and viral infections
  • Patients with ECG abnormalities that make it uninterpretable for ischemic purposes
  • Patients with previous coronary events
  • History of heart failure
  • Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis
  • Conditions involving increases in sST2 and suPAR unrelated to cardiac causes, especially acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, neoplasms, moderate-to-severe pulmonary fibrosis, chronic hepatopathy; autoimmune diseases)

结局指标

主要结局

The predictive value of markers for the risk of cardiovascular events in chest pain

时间窗: 2 years

Evaluate the medium-long term (1 year) predictive value of the sST2, suPAR and IL6 biomarkers in patients attending the emergency department for acute non-STEMI chest pain

次要结局

  • Multimarker approach to improve cardiovascular risk stratification(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piccioni Andrea

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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