Skip to content

Myocardial Injury and Severe Pneumococcal Pneumonia

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03058211
Acronym
NEUMOCAR
Enrollment
23
Registered
2017-02-20
Start date
2018-03-01
Completion date
2019-12-31
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pneumococcal, Myocardial Ischemia

Keywords

Pneumococcal pneumonia, 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 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.

Interventions

DIAGNOSTIC_TESTEchocardiography

Standard protocols

MRI with late gadolinium increase and T1 mapping

Sponsors

Alejandro Rodriguez Oviedo , MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardian injury (scarring) in patients with CAP without cardiac disease (CP)history at 6 months of ICU admissionat 6 monthsMRI 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 admissionat day 7 of ICU admission)Echocardiography with standard and strain techniques for to detect the presence of decrease in ejection fraction of both vetricules

Secondary

MeasureTime frameDescription
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 admissiononce 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 admissiononce 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 admissiononce per day (days 1 to 7 of ICU admission)Determination of serum heart- fatty acid binding protein (h-Fabp)according to standard technique

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026