Pneumonia, PneumococcalNEUMOCARNCT03058211
Myocardial Injury and Severe Pneumococcal Pneumonia
An observational study of Pneumonia, Pneumococcal and Myocardial Ischemia, run by Alejandro Rodriguez Oviedo , MD at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal, Myocardial Ischemia
- What is being tested?
- Echocardiography and Cardiac Magnetic resonance
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 31 Dec 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically ill patients admitted to the intensive care unit due to severe community-acquired pneumonia
Who may be able to join
- - Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
- - No history of heart diasese
- - Informed consent signed
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Critical Care Department - Hospital Universitario de Tarragona Joan XXIII
Tarragona, 43007
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Pneumococcal, Myocardial Ischemia
- Being tested
- Echocardiography, Cardiac Magnetic resonance
- Keywords
- Pneumococcal pneumonia, Acute cardiovascular events
- Medical subject headings
- Pneumonia, Pneumococcal, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Also called Heart resonance magnetic nuclear
Standard protocols
Cardiac Magnetic resonanceDiagnostic test
Also called MRI
MRI with late gadolinium increase and T1 mapping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic resonance | |
| 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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardian injury (scarring) in patients with CAP without cardiac disease (CP)history at 6 months of ICU admission
MRI with late gadolinium increase and t1 mapping techniques for to detect myocardial scarring
Measured: at 6 months
Heart dysfunction in patients with CAP without cardiac disease (CP)history in the first week of ICU admission
Echocardiography with standard and strain techniques for to detect the presence of decrease in ejection fraction of both vetricules
Measured: at day 7 of ICU admission)
Secondary outcomes (3)
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
Determination of serum troponin-I according to standard technique
Measured: 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
Determination of serum N-terminal pro-brain natriuretic peptide(NT-proBNP) according to standard technique
Measured: 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
Determination of serum heart- fatty acid binding protein (h-Fabp)according to standard technique
Measured: once per day (days 1 to 7 of ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Mar 2018
- Primary completion31 May 2019
- Study completion31 Dec 2019
Why it stopped: due to COVID-19 pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, PneumococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Alejandro Rodriguez Oviedo , MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alejandro Rodriguez Oviedo , MD, Hospital Universitari Joan XXIII de Tarragona.
- Investigators
- Alejandro H Rodriguez Oviedo, Principal investigator, Hospital Universitari de Tarragona Joan XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058211
- Sponsor's protocol ID
- PI16/00486
- Acronym
- NEUMOCAR
- Status last verified
- Jun 2021
- First submitted
- 10 Feb 2017
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corrales-Medina VF, Musher DM, Shachkina S, Chirinos JA. Acute pneumonia and the cardiovascular system. Lancet. 2013 Feb 9;381(9865):496-505. doi: 10.1016/S0140-6736(12)61266-5. Epub 2013 Jan 16.
PubMed 23332146Alhamdi Y, Neill DR, Abrams ST, Malak HA, Yahya R, Barrett-Jolley R, Wang G, Kadioglu A, Toh CH. Circulating Pneumolysin Is a Potent Inducer of Cardiac Injury during Pneumococcal Infection. PLoS Pathog. 2015 May 14;11(5):e1004836. doi: 10.1371/journal.ppat.1004836. eCollection 2015 May.
PubMed 25973949Brown AO, Mann B, Gao G, Hankins JS, Humann J, Giardina J, Faverio P, Restrepo MI, Halade GV, Mortensen EM, Lindsey ML, Hanes M, Happel KI, Nelson S, Bagby GJ, Lorent JA, Cardinal P, Granados R, Esteban A, LeSaux CJ, Tuomanen EI, Orihuela CJ. Streptococcus pneumoniae translocates into the myocardium and forms unique microlesions that disrupt cardiac function. PLoS Pathog. 2014 Sep 18;10(9):e1004383. doi: 10.1371/journal.ppat.1004383. eCollection 2014 Sep.
PubMed 25232870Lee YJ, Lee H, Park JS, Kim SJ, Cho YJ, Yoon HI, Lee JH, Lee CT, Park JS. Cardiac troponin I as a prognostic factor in critically ill pneumonia patients in the absence of acute coronary syndrome. J Crit Care. 2015 Apr;30(2):390-4. doi: 10.1016/j.jcrc.2014.12.001. Epub 2014 Dec 4.
PubMed 25534985
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Injury in Severe Pneumococcal Pneumonia as a Cause of Mortality From Acute Cardiovascular Events
- ClinicalTrials.gov ID
- NCT03058211
- Acronym / sponsor ID
- NEUMOCAR / PI16/00486
- Conditions
- Pneumonia, Pneumococcal, Myocardial Ischemia
- Keywords
- Pneumococcal pneumonia, Acute cardiovascular events
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to COVID-19 pandemia
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Alejandro Rodriguez Oviedo , MDUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneumococcal pneumonia | – | Diagnostic Test: Echocardiography, Diagnostic Test: Cardiac Magnetic resonancePatients 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. |
| non-pneumococcal pneumonia | – | Diagnostic Test: Echocardiography, Diagnostic Test: Cardiac Magnetic resonancePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to the intensive care unit due to severe community-acquired pneumonia
Key inclusion criteria (3 listed)
- - Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
- - No history of heart diasese
- - Informed consent signed
Key exclusion criteria (8 listed)
- - Hospital or ventilator-associated pneumonia
- - Health care-associated pneumonia
- - Viral pneumonia
- - Bacterial/viral coinfection pneumonia
- - History of heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAlso: Heart resonance magnetic nuclearStandard protocols | Diagnostic test | non-pneumococcal pneumonia, pneumococcal pneumonia |
| Cardiac Magnetic resonanceAlso: MRIMRI with late gadolinium increase and T1 mapping | Diagnostic test | non-pneumococcal pneumonia, pneumococcal pneumonia |
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study was stopped early (reason given: due to COVID-19 pandemia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Background: PubMed 23332146Corrales-Medina VF, Musher DM, Shachkina S, Chirinos JA. Acute pneumonia and the cardiovascular system. Lancet. 2013 Feb 9;381(9865):496-505. doi: 10.1016/S0140-6736(12)61266-5. Epub 2013 Jan 16.
- Background: PubMed 25973949Alhamdi Y, Neill DR, Abrams ST, Malak HA, Yahya R, Barrett-Jolley R, Wang G, Kadioglu A, Toh CH. Circulating Pneumolysin Is a Potent Inducer of Cardiac Injury during Pneumococcal Infection. PLoS Pathog. 2015 May 14;11(5):e1004836. doi: 10.1371/journal.ppat.1004836. eCollection 2015 May.
- Background: PubMed 25232870Brown AO, Mann B, Gao G, Hankins JS, Humann J, Giardina J, Faverio P, Restrepo MI, Halade GV, Mortensen EM, Lindsey ML, Hanes M, Happel KI, Nelson S, Bagby GJ, Lorent JA, Cardinal P, Granados R, Esteban A, LeSaux CJ, Tuomanen EI, Orihuela CJ. Streptococcus pneumoniae translocates into the myocardium and forms unique microlesions that disrupt cardiac function. PLoS Pathog. 2014 Sep 18;10(9):e1004383. doi: 10.1371/journal.ppat.1004383. eCollection 2014 Sep.
- Background: PubMed 25534985Lee YJ, Lee H, Park JS, Kim SJ, Cho YJ, Yoon HI, Lee JH, Lee CT, Park JS. Cardiac troponin I as a prognostic factor in critically ill pneumonia patients in the absence of acute coronary syndrome. J Crit Care. 2015 Apr;30(2):390-4. doi: 10.1016/j.jcrc.2014.12.001. Epub 2014 Dec 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro H Rodriguez Oviedo principal investigator
Hospital Universitari de Tarragona Joan XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumococcal and Myocardial Ischemia, run by Alejandro Rodriguez Oviedo , MD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to COVID-19 pandemia). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardian injury (scarring) in patients with CAP without cardiac disease (CP)history at 6 months of ICU admission (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058211, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.