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OpenTrials
Completed

NCT Number: NCT05253937

Impact of Intracoronary Versus Intravenous Epinephrine Administration During Cardiac Arrest .

In hospital cardiac arrest (IHCA) is a major challenge imposed on almost all health care systems worldwide. Despite significant progress in cardiopulmonary resuscitation in the past few years, outcomes remain relatively poor with an approximate 49 % survival rate.

Epinephrine administration remains a cornerstone in the treatment of cardiac arrest. However, the preferred route of administration remains a matter of debate within the medical community .

Various routes of administration, including intravenous, intramuscular, intraosseous and endotracheal routes have been studied.

Initially, American guidelines for the treatment of cardiac arrest recommended injection of 0.5 mg of epinephrine directly into the right ventricle through the parasternal approach, aiming to achieve higher peak intracardiac concentrations and a more central effect, however the intravenous route remained preferable due to its feasibility and safety .

To our knowledge, intra-coronary epinephrine administration for intraprocedural cardiac arrest has not been evaluated or compared with other routes of administration.

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Key information

Conditions

Cardiopulmonary Arrest Cardiovascular Diseases Epinephrine Causing Adverse Effects in Therapeutic Use Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ali Aldujeli

Kaunas, LT-50161, Lithuania

Who can participate

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

Inclusion criteria

  • Aged above 18 years old
  • Diagnosed with non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
  • Received dual antiplatelet therapy (acetylsalicylic acid and ticagrelor), or triple therapy (oral anticoagulant, acetylsalicylic acid and clopidogrel)
  • Event of cardiac arrest during percutaneous intervention

Exclusion criteria

  • cardiac arrest documented prior to being transported to cardiac catheterization laboratory.
  • Patients who suffered cardiac arrest for less than 60 seconds were excluded from the study.
  • Received mechanical circulatory support such as intra-aortic balloon pump, temporary percutaneous ventricular assist devices, or extracorporeal membrane oxygenation (ECMO) during hospitalization.
  • Presenting with any cardiac rhythm on admission other than sinus rhythm or atrial fibrillation/flutter
  • Signs of infection or a history of hepatic, oncologic or allergy to contrast media and end stage renal failure
  • Patients who underwent primary fibrinolysis.
  • Furthermore, patients who received atropine, amiodarone, lidocaine, or any other antiarrhythmic prior to CPR
  • who received targeted temperature management post CPR .

Treatment and study plan

Epinephrin

Drug

The study will enroll acute myocardial infarction patients who suffered from a cardiac arrest in the cardiac catheterization laboratory during percutaneous intervention procedure. Cardiac Resuscitation was performed according to the European Resuscitation Council (ERC) Guidelines. The preferred route of epinephrine administration was through the central venous access (by internal jugular or subclavian vein). Thus, if available, it was the preferred method of medication delivery. However, in cases without central venous access, the route of epinephrine administration (peripheral intravenous or arterial intracoronary) during cardiac arrest was left to the treating physicians.

Primary outcomes

  1. ROSC (return of spontaneous circulation) between different routes of epinephrine administration.

    Time frame: Up to 24 hours

    Return of sinus rhythm or atrial fibrillation/flutter for more than 5 minutes (through ECG monitoring)

Secondary outcomes

  1. Survival to hospital discharge with favorable neurologic status (CPC score1-2)

    Time frame: Up to 30 days

    Cerebral Performance Category (CPC) - a five point scale that ranges from good cerebral performance (1) to brain death (5), is often used and is commonly dichotomized into "good" (CPC 1-2) versus "poor" (CPC 3-5) outcome .

Other outcomes

  1. inhospital stent thrombosis

    Time frame: Up to 30 days

    Stent thrombosis confirmed by diagnostic angiography or sudden ST elevation on ECG in the specific segments confounding with stent location

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Baylor Scott and White Health
  • Minneapolis Heart Institute

Registry information

Official study title

Impact of Intracoronary Versus Central and Peripheral Intravenous Epinephrine Administration During Cardiac Arrest in The Cardiac Catheterization Laboratory for Acute Myocardial Infarction Patients.

Acronym: (iCPR)

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Aug 16, 2022

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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