Myocardial Injury and Severe Pneumococcal Pneumonia

Myocardial Ischemia Clinical Trial

— NEUMOCAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03058211
• Other study ID #: PI16/00486
• Status: Terminated
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: Hospital Universitari Joan XXIII de Tarragona.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischemia
• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Diagnostic Test:
• Echocardiography
Standard protocols
• Cardiac Magnetic resonance
MRI with late gadolinium increase and T1 mapping

Locations

Country	Name	City	State
Spain	Critical Care Department - Hospital Universitario de Tarragona Joan XXIII	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Alejandro Rodriguez Oviedo , MD

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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	once per day (days 1 to 7 of ICU admission)
Secondary	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)