Myocardial Injury and Severe Pneumococcal Pneumonia (NEUMOCAR)

June 29, 2021 updated by: Alejandro Rodriguez Oviedo , MD

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Tarragona, Spain, 43007
        • Critical Care Department - Hospital Universitario de Tarragona Joan XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients admitted to the intensive care unit due to severe community-acquired pneumonia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pneumococcal pneumonia
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.
Diagnostic test: Echocardiography
Standard protocols
Other Names:
  • Heart resonance magnetic nuclear
Diagnostic test: Cardiac Magnetic resonance
MRI with late gadolinium increase and T1 mapping
Other Names:
  • MRI
non-pneumococcal pneumonia
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.
Diagnostic test: Echocardiography
Standard protocols
Other Names:
  • Heart resonance magnetic nuclear
Diagnostic test: Cardiac Magnetic resonance
MRI with late gadolinium increase and T1 mapping
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 months
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
at day 7 of ICU admission)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
once per day (days 1 to 7 of ICU admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alejandro Rodriguez Oviedo , MD

Investigators

  • Principal Investigator: Alejandro H Rodriguez Oviedo, Hospital Universitari de Tarragona Joan XXIII

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

May 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (ACTUAL)

February 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: PI16/00486
    Information comments: Protocol in Spanish language
  2. Informed Consent Form
    Information identifier: PI16/00486
    Information comments: Informed consent form in Spanish language

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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