Out-Of-Hospital Cardiac ArrestPEACENCT04096079
Post-ROSC Electrocardiogram After Cardiac arrEst
An observational study of Out-Of-Hospital Cardiac Arrest and Infarction, Myocardial, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
PEACE study retrospectively evaluate patients who suffered an out-hospital cardiac arrest (OHCA) and who underwent a coronary angiography, enrolled in the registry of the Province of Pavia (Italy), Ticino Region (Switzerland), Wien region (Austria) and Nicosia area (Cyprus) to comprehend the best timing for post-ROSC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Infarction, Myocardial
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2019
- 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: OHCA patients
Who may be able to join
- All the patients older than 18 years old resuscitated from an out-of-hospital cardiac arrest with an available post-ROSC twelve leads ECG who underwent to a coronary angiography during hospital stay.
Who cannot join
- From the present study are excluded all the patients with a non-medical aetiology of the cardiac arrest (trauma, drowning, electrocution, drug or abuse substance overdose, asphyxia)
About this study
PEACE study retrospectively evaluate patients who suffered an out-hospital cardiac arrest (OHCA) and who underwent a coronary angiography, enrolled in the registry of the Province of Pavia (Italy), Ticino Region (Switzerland), Wien region (Austria) and Nicosia area (Cyprus) to comprehend the best timing for post-ROSC ECG acquisition in order to reduce the number of false positive and to select the best candidates for emergency coronary angiography.
Read the detailed description
Twelve leads electrocardiogram (ECG) represents an essential step of the diagnostic workflow after ROSC as stated by both the European and the American guidelines. Actually about 80% of patients showing an ST segment elevation after return of spontaneous circulation (ROSC) have a coronary lesion documented by coronary angiography. In those patients, early coronary angiography has been shown to improve survival with good neurologic outcome. More controversial is the scene for patients without an ST segment elevation. Even in the absence of ST segment elevation an acute coronary syndrome can be at the basis of cardiac arrest. However, the prognostic role of early coronary angiography in such patients is still a matter of debate. In 2014 a consensus document by the European Association for Percutaneous Cardiovascular Interventions (EAPCI) recommended elevation to consider early coronary angiography only in the case of hemodynamic instability or of recurrent ventricular arrhythmias for patients without ST segment as in the case of NSTEMI patients without cardiac arrest. At the light of these considerations the correct diagnosis of ST segment elevation is of pivotal importance for the right treatment in the right time and in the right hospital for this type of patients. Moreover, during cardiac arrest and during resuscitation the heart is suffering of ischemia deriving both from a coronary occlusion if present and from low systemic perfusion. Post-ROSC ECG could reflect both these types of ischemia, so the ST elevation could be not specific for a coronary occlusion. However, some time after ROSC, in case of absence of a coronary occlusion, the heart perfusion should improve, the ischemia should decrease and the ST segment elevation should regress. Nevertheless, current guidelines do not provide any indication about the best timing for ECG acquisition after ROSC. We believe that address this issue could be important in order to correctly discriminate the appropriate candidate for emergency coronary angiography in the post-ROSC phase of a cardiac arrest.
A preliminary analysis performed on a population of patients suffering an OHCA in the Province of Pavia supported this hypothesis. It was pointed out that early detection of ST segment elevation, within ten minutes from ROSC, was associated to a high number of false positives that is to say patients without an identifiable coronary culprit lesion. ST segment elevation was found to be an independent predictor of coronary angioplasty only if detected after ten minutes from ROSC.
The PEACE study aimed to confirm our preliminary results on a larger and multicentric sample of post ROSC patients.
- Keywords
- Out-Of-Hospital Cardiac Arrest, STEMI, coronary angiography, post-ROSC ECG
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Myocardial Infarction, ST Elevation Myocardial Infarction
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 |
|---|---|---|
| OHCA patients | Patients who suffered an out-of-hospital cardiac arrest between 2015 and 2018 in Province of Pavia (Italy), Ticino Region (Switzerland), Wien area (Austria) and Nicosia area (Cyprus) who underwent a coronary angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint - PCI
To assess the number of patients requiring a coronary angioplasty in the presence of ST segment elevation according to the ROSC-ECG time
Measured: Up to 14 days after OHCA (hospital discharge)
Primary endpoint - Time
To identify the ROSC-ECG time associated to the lowest rate of false positive
Measured: Up to 14 days after OHCA (hospital discharge)
Secondary outcomes (2)
Secondary outcome - PCI in STEMI patients
to assess the number of patients requiring a coronary angioplasty in the absence of ST segment elevation
Measured: Up to 14 days after OHCA (hospital discharge)
Secondary outcome - PCI in BBB patients
to assess the number of patients requiring a coronary angioplasty in the presence of left or right bundle branch block
Measured: Up to 14 days after OHCA (hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Nicosia General Hospital, Cardiocentro Ticino, Medical University of Vienna
- Responsible party
- Principal investigator, Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096079
- Sponsor's protocol ID
- PEACE Study
- Acronym
- PEACE
- Status last verified
- Feb 2020
- First submitted
- 14 Sep 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ROSC Electrocardiogram After Cardiac arrEst
- ClinicalTrials.gov ID
- NCT04096079
- Acronym / sponsor ID
- PEACE / PEACE Study
- Keywords
- Out-Of-Hospital Cardiac Arrest, STEMI, coronary angiography, post-ROSC ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Nicosia General Hospital, Cardiocentro Ticino, Medical University of Vienna
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Sep 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.
PEACE study retrospectively evaluate patients who suffered an out-hospital cardiac arrest (OHCA) and who underwent a coronary angiography, enrolled in the registry of the Province of Pavia (Italy), Ticino Region (Switzerland), Wien region (Austria) and Nicosia area (Cyprus) to comprehend the best timing for post-ROSC ECG acquisition in order to reduce the number of false positive and to select the best candidates for emergency coronary angiography.
Detailed description
Twelve leads electrocardiogram (ECG) represents an essential step of the diagnostic workflow after ROSC as stated by both the European and the American guidelines. Actually about 80% of patients showing an ST segment elevation after return of spontaneous circulation (ROSC) have a coronary lesion documented by coronary angiography. In those patients, early coronary angiography has been shown to improve survival with good neurologic outcome. More controversial is the scene for patients without an ST segment elevation. Even in the absence of ST segment elevation an acute coronary syndrome can be at the basis of cardiac arrest. However, the prognostic role of early coronary angiography in such patients is still a matter of debate. In 2014 a consensus document by the European Association for Percutaneous Cardiovascular Interventions (EAPCI) recommended elevation to consider early coronary angiography only in the case of hemodynamic instability or of recurrent ventricular arrhythmias for patients without ST segment as in the case of NSTEMI patients without cardiac arrest. At the light of these considerations the correct diagnosis of ST segment elevation is of pivotal importance for the right treatment in the right time and in the right hospital for this type of patients. Moreover, during cardiac arrest and during resuscitation the heart is suffering of ischemia deriving both from a coronary occlusion if present and from low systemic perfusion. Post-ROSC ECG could reflect both these types of ischemia, so the ST elevation could be not specific for a coronary occlusion. However, some time after ROSC, in case of absence of a coronary occlusion, the heart perfusion should improve, the ischemia should decrease and the ST segment elevation should regress. Nevertheless, current guidelines do not provide any indication about the best timing for ECG acquisition after ROSC. We believe that address this issue could be important in order to correctly discriminate the appropriate candidate for emergency coronary angiography in the post-ROSC phase of a cardiac arrest.
A preliminary analysis performed on a population of patients suffering an OHCA in the Province of Pavia supported this hypothesis. It was pointed out that early detection of ST segment elevation, within ten minutes from ROSC, was associated to a high number of false positives that is to say patients without an identifiable coronary culprit lesion. ST segment elevation was found to be an independent predictor of coronary angioplasty only if detected after ten minutes from ROSC.
The PEACE study aimed to confirm our preliminary results on a larger and multicentric sample of post ROSC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA patients | – | –Patients who suffered an out-of-hospital cardiac arrest between 2015 and 2018 in Province of Pavia (Italy), Ticino Region (Switzerland), Wien area (Austria) and Nicosia area (Cyprus) who underwent a coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OHCA patients
Key inclusion criteria (1 listed)
- All the patients older than 18 years old resuscitated from an out-of-hospital cardiac arrest with an available post-ROSC twelve leads ECG who underwent to a coronary angiography during hospital stay.
Key exclusion criteria (1 listed)
- From the present study are excluded all the patients with a non-medical aetiology of the cardiac arrest (trauma, drowning, electrocution, drug or abuse substance overdose, asphyxia)
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
Primary endpoint - PCI
Time frame: Up to 14 days after OHCA (hospital discharge)
To assess the number of patients requiring a coronary angioplasty in the presence of ST segment elevation according to the ROSC-ECG time
Primary endpoint - Time
Time frame: Up to 14 days after OHCA (hospital discharge)
To identify the ROSC-ECG time associated to the lowest rate of false positive
2 secondary outcomes
Secondary outcome - PCI in STEMI patients
Time frame: Up to 14 days after OHCA (hospital discharge)
Secondary outcome - PCI in BBB patients
Time frame: Up to 14 days after OHCA (hospital discharge)
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 12 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Infarction, Myocardial, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 1 inclusion and 1 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 12 Feb 2020. 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?
Primary endpoint - PCI (time frame: Up to 14 days after OHCA (hospital discharge)). 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 12 Feb 2020.