Myocardial Injury and Severe Pneumococcal Pneumonia (NEUMOCAR)

Alejandro Rodriguez Oviedo , MD

Status: Terminated

Conditions: Myocardial Ischemia; Pneumonia, Pneumococcal

Treatments: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic resonance

Study type: Observational

Funder types: Other

Identifiers

NCT03058211

PI16/00486

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. • Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
2. • No history of heart diasese
3. • Informed consent signed

Exclusion criteria

1. • Hospital or ventilator-associated pneumonia
2. • Health care-associated pneumonia
3. • Viral pneumonia
4. • Bacterial/viral coinfection pneumonia
5. • History of heart disease
6. • Chronic administration of statins
7. • Chronic administration of steorids (Prednisolone more 20 mg/day or equivalent)
8. • No signed informed consent

Trial design

23 participants in 2 patient groups

pneumococcal pneumonia

Description:

Patients with community-acquired pneumonia due to S.pneumoniae. An Echocardiography will be performed to all patients (one per day during 7 days). A Cardiac magnetic resonance (MRI) will be performed during an acute episode and at month 6 since ICU admission. In addition a blood sample will be drawn daily (one per day during 7 days) to measure myocardial injury and inflammation systemic (interleukins) biomarkers.

Treatment:

Diagnostic Test: Cardiac Magnetic resonance

Diagnostic Test: Echocardiography

non-pneumococcal pneumonia

Description:

Patients with community-acquired pneumonia due to S.pneumoniae. An Echocardiography will be performed to all patients (one per day during 7 days). A Cardiac magnetic resonance (MRI) will be performed during an acute episode and at month 6 since ICU admission. In addition a blood sample will be drawn daily (one per day during 7 days) to measure myocardial injury and inflammation systemic (interleukins) biomarkers.

Treatment:

Diagnostic Test: Cardiac Magnetic resonance

Diagnostic Test: Echocardiography