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due to COVID-19 pandemia
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | Standard protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | at day 7 of ICU admission) |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients admitted to the intensive care unit due to severe community-acquired pneumonia
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro H Rodriguez Oviedo | Hospital Universitari de Tarragona Joan XXIII | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Department - Hospital Universitario de Tarragona Joan XXIII | Tarragona | 43007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332146 | Background | 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. | |
| 25973949 | Background | Alhamdi 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PI16/00486 | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cardiac Magnetic resonance | Diagnostic Test | MRI with late gadolinium increase and T1 mapping |
|
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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 | Determination of serum heart- fatty acid binding protein (h-Fabp)according to standard technique | once per day (days 1 to 7 of ICU admission) |
| 25232870 | Background | Brown 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. |
| 25534985 | Background | Lee 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. |
Protocol in Spanish language |
| PI16/00486 | Informed Consent Form | View IPD | Informed consent form in Spanish language |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |