Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest

Last updated: June 17, 2024
Sponsor: Uppsala University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Immediate coronary angiography

Clinical Study ID

NCT02309151
DSC001
  • Ages > 18
  • All Genders

Study Summary

The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Witnessed out of hospital cardiac arrest

  • Restoration of Spontaneous Circulation (ROSC) >20 minutes

  • Coronary angiography is expected to be performed within 120 minutes from inclusionand randomization at hospital

Exclusion

Exclusion Criteria:

  • Patient age <18 years

  • Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock,and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke)

  • Terminally ill patients with a life expectancy of less than 1 year

  • Patients with ST-elevation

  • Known pregnancy

  • Patient awake GCS >8 (Glasgow Coma Scale)

Study Design

Total Participants: 1006
Treatment Group(s): 1
Primary Treatment: Immediate coronary angiography
Phase:
Study Start date:
December 01, 2014
Estimated Completion Date:
December 31, 2024

Study Description

The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.

Connect with a study center

  • Aalborg University hospital

    Aalborg,
    Denmark

    Terminated

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Odense University hospital

    Odense,
    Denmark

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Hospital

    Dordrecht,
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Treant Hospital

    Emmen,
    Netherlands

    Active - Recruiting

  • Zuyderland Hospital

    Heerlen,
    Netherlands

    Active - Recruiting

  • Antonius Hospital

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Haaglanden Medisch Centrum

    The Hague,
    Netherlands

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Göteborg,
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Huddinge,
    Sweden

    Terminated

  • Skånes Universitetssjukhus

    Lund,
    Sweden

    Terminated

  • Skåne Universitetssjukhus

    Malmö,
    Sweden

    Terminated

  • Karolinska Universitetssjukhuset

    Solna,
    Sweden

    Active - Recruiting

  • Danderyd Sjukhus

    Stockholm,
    Sweden

    Terminated

  • Södersjukhuset AB

    Stockholm,
    Sweden

    Active - Recruiting

  • Umeå Universitetssjukhus

    Umeå,
    Sweden

    Active - Recruiting

  • Uppsala University hospital

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Örebro Universitetssjukhus

    Örebro,
    Sweden

    Terminated

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