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MACCE in Hospitalized Patients With Community-acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01773863
Recruitment Status : Recruiting
First Posted : January 23, 2013
Last Update Posted : September 17, 2018
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Brief Summary:

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 or disease
Community-acquired Pneumonia

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Major Adverse Cardiac and Cerebrovascular Events in Hospitalized Patients With Community-acquired Pneumonia
Study Start Date : October 2011
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Platelet activation, clotting abnormalities, myocardial damage and inflammation in CAP patients [ Time Frame: 2 years ]
    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 :
  1. Major adverse cardiac and cerebrovascular events [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773863

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Contact: Francesco Violi, MD 064461933 ext +39
Contact: Roberto Cangemi, MD 0649970103 ext +39

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Internal and Medical Specialities Department - Policlinico Umberto I Recruiting
Rome, Italy, 00162
Contact: Francesco Violi, MD    064461933 ext +39   
Contact: Roberto Cangemi, MD    0649970103   
Principal Investigator: Francesco Violi, MD         
Sub-Investigator: Cangemi Roberto, MD         
Sponsors and Collaborators
University of Roma La Sapienza
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Study Chair: Francesco Violi, MD Sapienza University of Rome
Publications of Results:
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Responsible Party: Francesco Violi, Director, Head of Internal Medicine, Clinical Professor, University of Roma La Sapienza Identifier: NCT01773863    
Other Study ID Numbers: MACCE and CAP
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Keywords provided by Francesco Violi, University of Roma La Sapienza:
Community-acquired pneumonia
Acute myocardial infarction
Platelet activation
Coagulation abnormalities,
NADPH oxidase
Major adverse cardiac and cerebrovascular events
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections