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

Fadoi Foundation, Italy1,266 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,266

Conditions

Cardiovascular Events

Interventions

No interventionOTHER

In this study there is no intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of CV events

To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).

Time frame: 17 months

Secondary Outcomes

Mortality

To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization

Time frame: 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

Time frame: 18 months

Impact of CV events

To assess the impact of CV events on the length of hospitalization

Time frame: 18 months

Risk factor

To evaluate risk factors for the occurrence of acute CV events

Time frame: 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

Time frame: 18 months

Data from ClinicalTrials.gov

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