MACCE in Hospitalized Patients With Community-acquired Pneumonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01773863
First received: January 18, 2013
Last updated: January 22, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Patients hospitalized for community-acquired pneumonia

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773863

Contacts
Contact: Francesco Violi, MD 064461933 ext +39 francesco.violi@uniroma1.it
Contact: Roberto Cangemi, MD 0649970103 ext +39 roberto.cangemi@uniroma1.it

Locations
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         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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 September 18, 2014