Myocardial Ischemia Clinical Trial
— NEUMOCAROfficial title:
Myocardial Injury in Severe Pneumococcal Pneumonia as a Cause of Mortality From Acute Cardiovascular Events
NCT number | NCT03058211 |
Other study ID # | PI16/00486 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | December 31, 2019 |
Verified date | June 2021 |
Source | Hospital Universitari Joan XXIII de Tarragona. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Critical Care Department - Hospital Universitario de Tarragona Joan XXIII | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Alejandro Rodriguez Oviedo , MD |
Spain,
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
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) |
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