Myocardial Injury in Severe Pneumococcal Pneumonia as a Cause of Mortality From Acute Cardiovascular Events
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Heart dysfunction in patients with CAP without cardiac disease (CP)history in the first week of ICU admission
研究概览
简要总结
Hypothesis: The "novo" cardiovascular events (CVE)in patients with severe community-acquired pneumonia (CAP) are frequent (17%) and could be associated with both direct pneumococcal myocardial invasion, toxin delivery (pneumolysin) or different biomarkers (histones, NETs(neutrophil extracellular traps), IL (Interleukin)-1b,h-Fabp (heart-Fatty acid bindding protein) ).The CVE frequency and its impact on outcome in patients without prior heart disease (CP) has not been studied.
Objectives:1) To determine the incidence of myocardian injury (MI) and CVE in patients with CAP without CP evaluated by non-invasive techniques (Echocardiograph and MRI) and biomarkers levels (Tn-I (Troponin I), h-Fabp, NT-proBNP (N-terminal pro-brain natriuretic peptide) histones, NETs, IL 1b); 2) To assess if DMA and CVE are related to the etiology and their impact on outcome , 3) To investigate the presence of myocardial scarring by MRI and its relationship with etiology and MI, and 4) To identify prognostic factors of DMA and CVE to determine level of risk.
详细描述
Area: Intensive care unit (ICU) of the participating hospitals. Patients: Forty patients with CAP without heart disease history will be included consecutively (20 patients with pneumococcal CAP and 20 patients with non-pneumococcal CAP).Ten healthy volunteers (controls) are included.
Variables: Epidemiological, clinical and hemodynamic variables are recorded. Presence of MI and CVE measured by echocardiography and by biomarkers will be evaluated during the ICU stay. Presence of scarring miocardic by MRI technique will be determined at month 6 since ICU admission.
Statistical analysis
Categorical (Fisher's exact test) and continuous variables( Wilconxon and Anova) will be used to determine differences between them. The Pearson correlation, ROC (discriminatory power) and logistic regression analysis(independent association) will be used to determine the association between variables and outcome. A p-value of 0.05 will be considered significant.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
- •No history of heart diasese
- •Informed consent signed
排除标准
- •Hospital or ventilator-associated pneumonia
- •Health care-associated pneumonia
- •Viral pneumonia
- •Bacterial/viral coinfection pneumonia
- •History of heart disease
- •Chronic administration of statins
- •Chronic administration of steorids (Prednisolone more 20 mg/day or equivalent)
- •No signed informed consent
结局指标
主要结局
Heart dysfunction in patients with CAP without cardiac disease (CP)history in the first week of ICU admission
时间窗: at day 7 of ICU admission)
Echocardiography with standard and strain techniques for to detect the presence of decrease in ejection fraction of both vetricules
Myocardian injury (scarring) in patients with CAP without cardiac disease (CP)history at 6 months of ICU admission
时间窗: at 6 months
MRI with late gadolinium increase and t1 mapping techniques for to detect myocardial scarring
次要结局
- Temporal profile of the Troponin I as a cardiac injury biomarker in patients with CAP without cardiac disease (CP)history in the first week of ICU admission(once per day ( days 1 to 7 of ICU admission))
- Temporal profile of the N-terminal pro-brain natriuretic peptide(NT-proBNP) as a cardiac injury biomarker in patients with CAP without cardiac disease (CP)history in the first week of ICU admission(once per day (days 1 to 7 of ICU admission))
- Temporal profile of the heart- fatty acid binding protein (h-Fabp) as a cardiac injury biomarker in patients with CAP without cardiac disease (CP)history in the first week of ICU admission(once per day (days 1 to 7 of ICU admission))
研究者
Alejandro Rodriguez Oviedo , MD
MD,PhD
Hospital Universitari Joan XXIII de Tarragona.