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Post-ROSC Electrocardiogram After Cardiac arrEst (PEACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096079
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
Nicosia General Hospital
Cardiocentro Ticino
Medical University of Vienna
Information provided by (Responsible Party):
Simone Savastano, IRCCS Policlinico S. Matteo

Brief 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 ECG acquisition in order to reduce the number of false positive and to select the best candidates for emergency coronary angiography.

Condition or disease
Out-Of-Hospital Cardiac Arrest Infarction, Myocardial

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-ROSC Electrocardiogram After Cardiac arrEst
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Secondary outcome - PCI in STEMI patients [ Time Frame: Up to 14 days after OHCA (hospital discharge) ]
    to assess the number of patients requiring a coronary angioplasty in the absence of ST segment elevation

  2. Secondary outcome - PCI in BBB patients [ Time Frame: Up to 14 days after OHCA (hospital discharge) ]
    to assess the number of patients requiring a coronary angioplasty in the presence of left or right bundle branch block



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
OHCA patients
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
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Responsible Party: Simone Savastano, MD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT04096079    
Other Study ID Numbers: PEACE Study
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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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 Simone Savastano, IRCCS Policlinico S. Matteo:
Out-Of-Hospital Cardiac Arrest, STEMI, coronary angiography, post-ROSC ECG
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases