Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.

Study Overview
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Brief Summary
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FADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine Operative Units, and for each of them a prospective registration of data relative to at least 50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.

Detailed Description
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Phase 1 - Patients enrollment (October 2016 - February 2018) Each Investigator have recorded data concerning 50 patients. It will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests, Phase 2 - Database review and validation (April 2018 - October 2018) The data collected will be analysed to process the endpoints.

Official Title
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Incidence and Prognostic Implication of Acute Cardiovascular Events in Patients Hospitalized for Community-acquired Pneumonia in Internal Medicine Units.The FADOI-ICECAP Study.

Conditions
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Cardiovascular Events

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of new infiltration associated with at least two of the following clinical features: fever > 37.8°C typical symptoms (dyspnea, productive cough, pain) typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion) leukocytosis Exclusion Criteria: patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission) patients with tuberculosis in active phase patients with cystic fibrosis patients who refuse to participate in the study and/or to give the written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CAP hospitalized in IM<br>Data of Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units will be collected for this study; no intervention is planned for this study | Other: No intervention<br>* In this study there is no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CV events | To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event). | 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization | 18 months | 
| Impact of acute CV events | To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days | 18 months | 
| Impact of CV events | To assess the impact of CV events on the length of hospitalization | 18 months | 
| Risk factor | To evaluate risk factors for the occurrence of acute CV events | 18 months | 
| Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia | To evaluate the incidence of CV complications in the group of patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-acquired pneumonia (CAP)