Cardiovascular EventsICECAPNCT03798457
Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.
An observational study of Cardiovascular Events, run by Fadoi Foundation, Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Events
- How many people
- 1,266 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 28 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Cardiovascular Events
- Being tested
- No intervention
- Keywords
- Community-acquired pneumonia (CAP)
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
In this study there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CV events
To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).
Measured: 17 months
Secondary outcomes (5)
Mortality
To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization
Measured: 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
Measured: 18 months
Impact of CV events
To assess the impact of CV events on the length of hospitalization
Measured: 18 months
Risk factor
To evaluate risk factors for the occurrence of acute CV events
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Oct 2016
- Primary completion28 Feb 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gualberto Gussoni, MD, Study director, Fadoi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798457
- Sponsor's protocol ID
- FADOI.06.2015
- Acronym
- ICECAP
- Status last verified
- Jan 2019
- First submitted
- 28 Dec 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33494707
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03798457
- Acronym / sponsor ID
- ICECAP / FADOI.06.2015
- Conditions
- Cardiovascular Events
- Keywords
- Community-acquired pneumonia (CAP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CAP hospitalized in IM | – | Other: No interventionData 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionIn this study there is no intervention | Other | Patients with CAP hospitalized in IM |
Primary outcome
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).
5 secondary outcomes
Mortality
Time frame: 18 months
Impact of acute CV events
Time frame: 18 months
Impact of CV events
Time frame: 18 months
Risk factor
Time frame: 18 months
Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 33494707Pieralli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gualberto Gussoni, MD study director
Fadoi Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Events, run by Fadoi Foundation, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CV events (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.