Cardiac ArrestIMPACT-ACCNCT06608771
Outcome of Cardiac Arrest Patients Following Guidelines Implementation Over the Years
An observational study of Cardiac Arrest, run by Mauro Panigada at 2 sites in Italy.
Trial summary
The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 693 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Jul 2024to 30 Mar 2026
- 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: All adult patients resuscitated from cardiac arrest and admitted to ICU over a 14-year-period
Who may be able to join
- Patients resuscitated from cardiac arrest and admitted to intensive care unit
- Age ≥ 18 years
- Out-of-hospital and in-hospital cardiac arrest
- Cardiac arrest of any etiology
Who cannot join
- Pediatric patients (<18 years)
- Patients not admitted to one of the aforementioned intensive care units.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Giuseppe Ristagno, MD, PhD, +390255033258, giuseppe.ristagno@unimi.it
Mauro Panigada, MD, +390255033258, mauro.panigada@policlinico.mi.it
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, 20900
Giuseppe Foti, MD, +390392339273, g.foti@asst-monza.it
Emanuele Rezoagli, MD, PhD, +390392339273, emanuele.rezoagli@unimib.it
About this study
Official title: Implementation of the New Guidelines on the Management of Patients Resuscitated From Cardiac Arrest and Impact on Survival: a Multicenter Retrospective Observational Study
The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. During this time period, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.
Read the detailed description
This study is a retrospective multicenter cohort observational study (two centers involved: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Fondazione IRCCS San Gerardo dei Tintori).
All patients admitted to the Intensive Care Units (ICU) of the hospitals involved in the study from January 1, 2011, to May 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.
- Conditions
- Cardiac Arrest
- Keywords
- Out-Of-Hospital Cardiac Arrest, In-Hospital Cardiac Arrest, Guidelines Implementation, Resuscitation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest (OHCA) and In-hospital cardiac arrest (IHCA) patients | The study population includes all adult patients resuscitated from cardiac arrest and subsequently admitted to the Intensive Care Unit over a 14-year-period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit (ICU) Survival
To evaluate ICU survival for patients resuscitated from cardiac arrest
Measured: From cardiac arrest date to ICU discharge or death, up to 90 days
Neurological recovery at ICU discharge
ICU Survival with Cerebral Performance Category (CPC) score of 1 or 2
Measured: From cardiac arrest date to ICU discharge or death, up to 90 days
Secondary outcomes (1)
Hospital discharge status
To evaluate hospital survival for patients resuscitated from cardiac arrest
Measured: From cardiac arrest date to hospital discharge or death, up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start26 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Retrospective
- Enrolment
- 693 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro Panigada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro Panigada, Policlinico Hospital
- Investigators
- Giuseppe Ristagno, MD, PhD, Principal investigator, IRCCS Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608771
- Sponsor's protocol ID
- 5033
- Acronym
- IMPACT-ACC
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the New Guidelines on the Management of Patients Resuscitated From Cardiac Arrest and Impact on Survival: a Multicenter Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06608771
- Acronym / sponsor ID
- IMPACT-ACC / 5033
- Conditions
- Cardiac Arrest
- Keywords
- Out-Of-Hospital Cardiac Arrest, In-Hospital Cardiac Arrest, Guidelines Implementation, Resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- Mauro PanigadaUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 23 Sep 2024 (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.
The study aims to evaluate the level of local implementation of the new interventions introduced by the guidelines for post-cardiac arrest management and their impact on the survival of patients resuscitated from cardiac arrest and admitted to intensive care over a 14-year period. During this time period, the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) introduced three new guidelines for post-cardiac arrest management, each five years apart: the 2010, 2015, and 2021 guidelines.
Detailed description
This study is a retrospective multicenter cohort observational study (two centers involved: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico and Fondazione IRCCS San Gerardo dei Tintori).
All patients admitted to the Intensive Care Units (ICU) of the hospitals involved in the study from January 1, 2011, to May 30, 2024, following cardiac arrest of any etiology, who meet the inclusion and exclusion criteria, will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest (OHCA) and In-hospital cardiac arrest (IHCA) patients | – | –The study population includes all adult patients resuscitated from cardiac arrest and subsequently admitted to the Intensive Care Unit over a 14-year-period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients resuscitated from cardiac arrest and admitted to ICU over a 14-year-period
Key inclusion criteria (4 listed)
- Patients resuscitated from cardiac arrest and admitted to intensive care unit
- Age ≥ 18 years
- Out-of-hospital and in-hospital cardiac arrest
- Cardiac arrest of any etiology
Key exclusion criteria (2 listed)
- Pediatric patients (<18 years)
- Patients not admitted to one of the aforementioned intensive care units.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensive Care Unit (ICU) Survival
Time frame: From cardiac arrest date to ICU discharge or death, up to 90 days
To evaluate ICU survival for patients resuscitated from cardiac arrest
Neurological recovery at ICU discharge
Time frame: From cardiac arrest date to ICU discharge or death, up to 90 days
ICU Survival with Cerebral Performance Category (CPC) score of 1 or 2
1 secondary outcome
Hospital discharge status
Time frame: From cardiac arrest date to hospital discharge or death, up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Giuseppe Ristagno, MD, PhD principal investigator
IRCCS Cà Granda Ospedale Maggiore Policlinico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Mauro Panigada at 2 sites in 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Ristagno, MD, PhD (+390255033258, giuseppe.ristagno@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Unit (ICU) Survival (time frame: From cardiac arrest date to ICU discharge or death, up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.