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

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ClinicalTrials.gov Identifier: NCT03798457
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Fadoi Foundation, Italy

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
Cardiovascular Events Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 1266 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort 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




Primary Outcome Measures :
  1. Incidence of CV events [ Time Frame: 17 months ]
    To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 18 months ]
    To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization

  2. Impact of acute CV events [ Time Frame: 18 months ]
    To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days

  3. Impact of CV events [ Time Frame: 18 months ]
    To assess the impact of CV events on the length of hospitalization

  4. Risk factor [ Time Frame: 18 months ]
    To evaluate risk factors for the occurrence of acute CV events

  5. Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798457


Sponsors and Collaborators
Fadoi Foundation, Italy
Investigators
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Study Director: Gualberto Gussoni, MD Fadoi Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fadoi Foundation, Italy
ClinicalTrials.gov Identifier: NCT03798457    
Other Study ID Numbers: FADOI.06.2015
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fadoi Foundation, Italy:
Community-acquired pneumonia (CAP)