Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03058211
Status:
TERMINATED
Last Update Posted:
2021-07-01
First Post:
2017-02-10
Brief Title:
Myocardial Injury and Severe Pneumococcal Pneumonia
Sponsor:
Alejandro Rodriguez Oviedo MD
Organization:
Hospital Universitari Joan XXIII de Tarragona
Study Overview
Official Title:
Myocardial Injury in Severe Pneumococcal Pneumonia as a Cause of Mortality From Acute Cardiovascular Events
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to COVID-19 pandemia
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUMOCAR
Brief Summary:
Hypothesis The novo cardiovascular events CVEin 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 NETsneutrophil extracellular traps IL Interleukin-1bh-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
Objectives1 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
Objectives1 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 CAPTen 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 Fishers 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 analysisindependent association will be used to determine the association between variables and outcome A p-value of 005 will be considered significant
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 Fishers 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 analysisindependent association will be used to determine the association between variables and outcome A p-value of 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None