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Completed

NCT Number: NCT03798457

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

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.

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Key information

Conditions

Cardiovascular Events Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

No intervention

Other

In this study there is no intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Official study title

Incidence and Prognostic Implication of Acute Cardiovascular Events in Patients Hospitalized for Community-acquired Pneumonia in Internal Medicine Units.The FADOI-ICECAP Study.

Acronym: ICECAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2019
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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