Myocardial Injury and Severe Pneumococcal Pneumonia

NCT03058211 | Terminated

• 1 other identifier: PI16/00486
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Pneumococcal; Myocardial Ischemia

Keywords

Pneumococcal pneumonia; Acute cardiovascular events

Outcome Measures

Primary Outcomes (2)

• 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)

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

  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

  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

  once per day (days 1 to 7 of ICU admission)

Study Arms (2)

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; 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.

Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic resonance

Interventions

Echocardiography DIAGNOSTIC_TEST

Standard protocols

Also known as: Heart resonance magnetic nuclear

non-pneumococcal pneumonia; pneumococcal pneumonia

Cardiac Magnetic resonance DIAGNOSTIC_TEST

MRI with late gadolinium increase and T1 mapping

Also known as: MRI

non-pneumococcal pneumonia; pneumococcal pneumonia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
• \- No history of heart diasese
• \- Informed consent signed

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Alejandro Rodriguez Oviedo , MD: lead

Study Sites (1)

Critical Care Department - Hospital Universitario de Tarragona Joan XXIII

Tarragona, 43007, Spain

Location

Related Publications (4)

• 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.

  PMID: 23332146 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.

  PMID: 25973949 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.

  PMID: 25232870 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.

  PMID: 25534985 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumococcal; Myocardial Ischemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Alejandro H Rodriguez Oviedo

  Hospital Universitari de Tarragona Joan XXIII

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)