Clinical Trial: Myocardial Injury and Severe Pneumococcal Pneumonia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: Myocardial Injury in Severe Pneumococcal Pneumonia as a Cause of Mortality From Acute Cardiovascular Events

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Alejandro Rodriguez Oviedo

Current Primary Outcome:

  • Myocardian injury (scarring) in patients with CAP without cardiac disease (CP)history at 6 months of ICU admission [ Time Frame: at 6 months ]
    MRI with late gadolinium increase and t1 mapping techniques for to detect myocardial scarring
  • Heart dysfunction in patients with CAP without cardiac disease (CP)history in the first week of ICU admission [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: once per day ( days 1 to 7 of ICU admission) ]
    Determination of serum troponin-I according to standard technique
  • 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 [ Time Frame: once per day (days 1 to 7 of ICU admission) ]
    Determination of serum N-terminal pro-brain natriuretic peptide(NT-proBNP) according to standard technique
  • 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 [ Time Frame: once per day (days 1 to 7 of ICU admission) ]
    Determination of serum heart- fatty acid binding protein (h-Fabp)according to standard technique


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Joan XXIII de Tarragona.

Dates:
Date Received: February 10, 2017
Date Started: October 1, 2017
Date Completion: December 31, 2020
Last Updated: February 15, 2017
Last Verified: February 2017