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

NCT03798457 | Completed

• 1 other identifier: FADOI.06.2015
• Study Type: observational
• Target: 1,266
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Events

Keywords

Community-acquired pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

• Incidence of CV events

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

  17 months

Secondary Outcomes (5)

• Mortality

  18 months

• Impact of acute CV events

  18 months

• Impact of CV events

  18 months

• Risk factor

  18 months

• Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia

  18 months

Study Arms (1)

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

Interventions

No intervention OTHER

In this study there is no intervention

Patients with CAP hospitalized in IM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units

You may qualify if:

• Age \> 18 years
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Related Publications (1)

• 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.

  PMID: 33494707 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Gualberto Gussoni, MD

  Fadoi Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 10, 2019
• Study Start: October 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: March 28, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01