Cardiovascular Events
Conditions
Keywords
Community-acquired pneumonia (CAP)
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.
Interventions
OTHERNo intervention
In this study there is no intervention
Sponsors
Fadoi Foundation, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CV events | 17 months | To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 18 months | To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization |
| Impact of acute CV events | 18 months | To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days |
| Impact of CV events | 18 months | To assess the impact of CV events on the length of hospitalization |
| Risk factor | 18 months | To evaluate risk factors for the occurrence of acute CV events |
| Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia | 18 months | 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 |
Outcome results
None listed