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

Cardiovascular Events Clinical Trial

— ICECAP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798457
• Other study ID #: FADOI.06.2015
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: March 28, 2018

Study information

• Verified date: January 2019
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: March 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Events

Intervention

Other:
• No intervention
In this study there is no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CV events	To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).	17 months
Secondary	Mortality	To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization	18 months
Secondary	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
Secondary	Impact of CV events	To assess the impact of CV events on the length of hospitalization	18 months
Secondary	Risk factor	To evaluate risk factors for the occurrence of acute CV events	18 months
Secondary	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