MACCE in Hospitalized Patients With Community-acquired Pneumonia

NCT01773863 | Unknown DMC

• 1 other identifier: MACCE and CAP
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumonia; Acute myocardial infarction; Platelet activation; Coagulation abnormalities,; Thrombosis; Isoprosantes; NADPH oxidase; Major adverse cardiac and cerebrovascular events

Outcome Measures

Primary Outcomes (1)

• Platelet activation, clotting abnormalities, myocardial damage and inflammation in CAP patients

  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

  2 years

Secondary Outcomes (1)

• Major adverse cardiac and cerebrovascular events

  2 years

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for community-acquired pneumonia

You may qualify if:

• community-acquired pneumonia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Internal and Medical Specialities Department - Policlinico Umberto I

Rome, 00162, Italy

RECRUITING

Related Publications (6)

• Cangemi R, Calvieri C, Bucci T, Carnevale R, Casciaro M, Rossi E, Calabrese CM, Taliani G, Grieco S, Falcone M, Palange P, Bertazzoni G, Celestini A, Pignatelli P, Violi F; SIXTUS study group. Is NOX2 upregulation implicated in myocardial injury in patients with pneumonia? Antioxid Redox Signal. 2014 Jun 20;20(18):2949-54. doi: 10.1089/ars.2013.5766. Epub 2014 Mar 14.

  PMID: 24328853 RESULT

• Cangemi R, Casciaro M, Rossi E, Calvieri C, Bucci T, Calabrese CM, Taliani G, Falcone M, Palange P, Bertazzoni G, Farcomeni A, Grieco S, Pignatelli P, Violi F; SIXTUS Study Group; SIXTUS Study Group. Platelet activation is associated with myocardial infarction in patients with pneumonia. J Am Coll Cardiol. 2014 Nov 4;64(18):1917-25. doi: 10.1016/j.jacc.2014.07.985. Epub 2014 Oct 27.

  PMID: 25444147 RESULT

• Cangemi R, Calvieri C, Falcone M, Bucci T, Bertazzoni G, Scarpellini MG, Barilla F, Taliani G, Violi F; SIXTUS Study Group. Relation of Cardiac Complications in the Early Phase of Community-Acquired Pneumonia to Long-Term Mortality and Cardiovascular Events. Am J Cardiol. 2015 Aug 15;116(4):647-51. doi: 10.1016/j.amjcard.2015.05.028. Epub 2015 May 22.

  PMID: 26089009 RESULT

• Violi F, Carnevale R, Calvieri C, Nocella C, Falcone M, Farcomeni A, Taliani G, Cangemi R; SIXTUS study group. Nox2 up-regulation is associated with an enhanced risk of atrial fibrillation in patients with pneumonia. Thorax. 2015 Oct;70(10):961-6. doi: 10.1136/thoraxjnl-2015-207178. Epub 2015 Jun 29.

  PMID: 26123660 RESULT

• Pastori D, Menichelli D, Romiti GF, Speziale AP, Pignatelli P, Basili S, Violi F, Cangemi R. Prediction of new-onset atrial fibrillation with the C2HEST score in patients admitted with community-acquired pneumonia. Infection. 2024 Aug;52(4):1539-1546. doi: 10.1007/s15010-024-02286-x. Epub 2024 May 3.

  PMID: 38700657 DERIVED

• Cangemi R, Carnevale R, Nocella C, Calvieri C, Bartimoccia S, Frati G, Pignatelli P, Picchio V, Violi F. Low-grade endotoxemia is associated with cardiovascular events in community-acquired pneumonia. J Infect. 2024 Feb;88(2):89-94. doi: 10.1016/j.jinf.2023.11.010. Epub 2023 Nov 23.

  PMID: 38000675 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and urine samples

MeSH Terms

Conditions

Community-Acquired Pneumonia; Thrombosis

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francesco Violi, MD

  University of Roma La Sapienza

  STUDY CHAIR

• Roberto Cangemi, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Roberto Cangemi

  Sapienza - Unviersity of Rome

  STUDY DIRECTOR

Central Study Contacts

Francesco Violi, MD

CONTACT

064461933; francesco.violi@uniroma1.it

Roberto Cangemi, MD

CONTACT

0649970103; roberto.cangemi@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Internal Medicine, Clinical Professor

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 23, 2013
• Study Start: October 1, 2011
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

IT (1)