ICECAP: Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with CAP hospitalized in IM 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
In this study there is no intervention
|
Outcome Measures
Primary Outcome Measures
- Incidence of CV events [17 months]
To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18 years
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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:
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fever > 37.8°C
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typical symptoms (dyspnea, productive cough, pain)
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typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion)
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leukocytosis
Exclusion Criteria:
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patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission)
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patients with tuberculosis in active phase
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patients with cystic fibrosis
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patients who refuse to participate in the study and/or to give the written informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fadoi Foundation, Italy
Investigators
- Study Director: Gualberto Gussoni, MD, Fadoi Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FADOI.06.2015