MACCE in Hospitalized Patients With Community-acquired Pneumonia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Community-acquired Pneumonia |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 250 |
| 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) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients hospitalized for community-acquired pneumonia
Inclusion Criteria:
- community-acquired pneumonia
Exclusion Criteria:
- presence of immunosuppression (HIV infection, high dose of immunosuppressive agents such as prednisone, chemotherapy);
- presence of malignancy;
- pregnancy or breast feeding;
- health care-associated pneumonia
Contacts and Locations| Contact: Francesco Violi, MD | 064461933 ext +39 | francesco.violi@uniroma1.it |
| Contact: Roberto Cangemi, MD | 0649970103 ext +39 | roberto.cangemi@uniroma1.it |
| Italy | |
| Internal and Medical Specialities Department - Policlinico Umberto I | Recruiting |
| Rome, Italy, 00162 | |
| Contact: Francesco Violi, MD 064461933 ext +39 francesco.violi@uniroma1.it | |
| Contact: Roberto Cangemi, MD 0649970103 roberto.cangemi@uniroma1.it | |
| Principal Investigator: Francesco Violi, MD | |
| Sub-Investigator: Cangemi Roberto, MD | |
| Study Chair: | Francesco Violi, MD | Sapienza - University of Rome |
More Information
No publications provided
| Responsible Party: | Francesco Violi, Director, Head of Internal Medicine, Clinical Professor, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01773863 History of Changes |
| Other Study ID Numbers: | MACCE and CAP |
| Study First Received: | January 18, 2013 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Italy: Ethics Commitee |
Keywords provided by University of Roma La Sapienza:
|
Community-acquired pneumonia Acute myocardial infarction Platelet activation Coagulation abnormalities, |
Thrombosis Isoprosantes NADPH oxidase Major adverse cardiac and cerebrovascular events |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 21, 2013