MACCE in Hospitalized Patients With Community-acquired Pneumonia
Recruitment status was Recruiting
Community-acquired pneumonia is the most common infection leading to hospitalization in intensive care units and the most common cause of death associated with infection disease.
Epidemiological studies have shown that respiratory tract infections are associated with an increased risk for the development of acute cardiovascular and cerebrovascular events.
This link is further supported by studies indicating that influenza vaccination is associated with a reduced risk of hospitalization for pneumonia as well as heart disease and cerebrovascular disease.
Data connecting acute respiratory tract infections and cardiovascular events stem almost exclusively from cross-sectional or retrospective studies. Thus the real incidence and the prognostic impact of AMI, as well as the pathophysiological relationship between pneumonia and cardiovascular damage is still elusive.
Inflammation plays a major role in the pathogenesis of coronary artery disease. The increased concentrations of proinflammatory cytokines together with the activation of coagulation, the down-regulation of anticoagulant mechanisms and the enhanced platelet aggregation may trigger atheroma's instability, plaque rupture and thrombus formation.
Inflammation and coagulopathy are also considered universal host responses to infection in patients with severe sepsis. Thus far limited data are available on the changes in these high regulated systems, together with platelet activity in patients with CAP and their potential relationship with cardiovascular risk.
This project will consist in a prospective multicenter study to investigate the incidence of major adverse cardiac and cerebrovascular events (MACCE) in hospitalized patients with CAP, its prognostic relevance and the potential relationship between enhanced cardiovascular risk and the activation of inflammation, coagulation and platelet aggregation in this setting.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Major Adverse Cardiac and Cerebrovascular Events in Hospitalized Patients With Community-acquired Pneumonia|
- Platelet activation, clotting abnormalities, myocardial damage and inflammation in CAP patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]Platelet and serum thromboxane, F2-isoprostanes, NOX2-activation, serum high-sensitivity cardiac troponin T, protein C and protein S at hospital admission and at hospital discharge
- Major adverse cardiac and cerebrovascular events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Major adverse cardiac and cerebrovascular events will be assessed during hospitalization and during the follow-up
Biospecimen Retention: Samples Without DNA
Plasma, serum and urine samples
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773863
|Contact: Francesco Violi, MD||064461933 ext +firstname.lastname@example.org|
|Contact: Roberto Cangemi, MD||0649970103 ext +email@example.com|
|Internal and Medical Specialities Department - Policlinico Umberto I||Recruiting|
|Rome, Italy, 00162|
|Contact: Francesco Violi, MD 064461933 ext +39 firstname.lastname@example.org|
|Contact: Roberto Cangemi, MD 0649970103 email@example.com|
|Principal Investigator: Francesco Violi, MD|
|Sub-Investigator: Cangemi Roberto, MD|
|Study Chair:||Francesco Violi, MD||Sapienza - University of Rome|