Clinical trial NCT03798457: Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.
Official title: Incidence and Prognostic Implication of Acute Cardiovascular Events in Patients Hospitalized for Community-acquired Pneumonia in Internal Medicine Units.The FADOI-ICECAP Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Events
Keywords: Community-acquired pneumonia (CAP)
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 1266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. 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.

Primary outcomes:
measure: Incidence of CV events
timeFrame: 17 months
Secondary outcomes:
measure: Mortality
timeFrame: 18 months
measure: Impact of acute CV events
timeFrame: 18 months
measure: Impact of CV events
timeFrame: 18 months
measure: Risk factor
timeFrame: 18 months
measure: Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Fadoi Foundation
name: Gualberto Gussoni, MD
role: STUDY_DIRECTOR
References:
citation: Pieralli F, Vannucchi V, Nozzoli C, Augello G, Dentali F, De Marzi G, Uomo G, Risaliti F, Morbidoni L, Mazzone A, Santini C, Tirotta D, Corradi F, Gerloni R, Gnerre P, Gussoni G, Valerio A, Campanini M, Manfellotto D, Fontanella A; FADOI-ICECAP Study Group. Acute cardiovascular events in patients with community acquired pneumonia: results from the observational prospective FADOI-ICECAP study. BMC Infect Dis. 2021 Jan 25;21(1):116. doi: 10.1186/s12879-021-05781-w.