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

NCT02309151 | Completed

• 1 other identifier: DSC001
• Study Type: interventional
• Target: 1,003
• Locations: 3 countries
• Sites: 21

Brief 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.

Conditions

Out-of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 30 day survival

  Follow up will be performed at 30 days, telephone call or visit.

  30 days

Secondary Outcomes (7)

• Survival with good neurological function

  30 days

• Survival at discharge from ICU (individual for each subject) and at 6-months

  At discharge from ICU, an expected average of 3-30 days and at 6-months

• Survival with good neurological function at discharge from ICU and 6-months

  At discharge from ICU, an expected average of 3-30 days and at 6-months

• Cardiac function

  72 hours and at 6 months

• Follow up of neurological function at 6-months

  Measured at 6 months

Study Arms (2)

Immediate coronary angiography

EXPERIMENTAL

Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC

Procedure: Immediate coronary angiography

Not immediate coronary angiography

NO INTERVENTION

Coronary angiography with possible coronary intervention may 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.

Interventions

Immediate coronary angiography PROCEDURE

Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC

Immediate coronary angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Witnessed out of hospital cardiac arrest
• Restoration of Spontaneous Circulation (ROSC) \>20 minutes

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (21)

Aalborg University hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Odense University hospital

Odense, Denmark

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Treant Hospital

Emmen, Netherlands

Location

Zuyderland Hospital

Heerlen, Netherlands

Location

Antonius Hospital

Nieuwegein, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Karolinska Universitetssjukhuset

Huddinge, Sweden

Location

Skånes Universitetssjukhus

Lund, Sweden

Location

Skåne Universitetssjukhus

Malmo, Sweden

Location

Örebro Universitetssjukhus

Örebro, Sweden

Location

Karolinska Universitetssjukhuset

Solna, Sweden

Location

Danderyd Sjukhus

Stockholm, Sweden

Location

Södersjukhuset AB

Stockholm, Sweden

Location

Umeå Universitetssjukhus

Umeå, Sweden

Location

Uppsala University hospital

Uppsala, 75185, Sweden

Location

Related Publications (3)

• Elfwen L, Lagedal R, Rubertsson S, James S, Oldgren J, Olsson J, Hollenberg J, Jensen U, Ringh M, Svensson L, Nordberg P. Post-resuscitation myocardial dysfunction in out-of-hospital cardiac arrest patients randomized to immediate coronary angiography versus standard of care. Int J Cardiol Heart Vasc. 2020 Mar 2;27:100483. doi: 10.1016/j.ijcha.2020.100483. eCollection 2020 Apr.

  PMID: 32154359 DERIVED

• Elfwen L, Lagedal R, Nordberg P, James S, Oldgren J, Bohm F, Lundgren P, Rylander C, van der Linden J, Hollenberg J, Erlinge D, Cronberg T, Jensen U, Friberg H, Lilja G, Larsson IM, Wallin E, Rubertsson S, Svensson L. Direct or subacute coronary angiography in out-of-hospital cardiac arrest (DISCO)-An initial pilot-study of a randomized clinical trial. Resuscitation. 2019 Jun;139:253-261. doi: 10.1016/j.resuscitation.2019.04.027. Epub 2019 Apr 24.

  PMID: 31028826 DERIVED

• Lagedal R, Elfwen L, James S, Oldgren J, Erlinge D, Ostlund O, Wallin E, Larsson IM, Lilja G, Cronberg T, Rubertsson S, Nordberg P. Design of DISCO-Direct or Subacute Coronary Angiography in Out-of-Hospital Cardiac Arrest study. Am Heart J. 2018 Mar;197:53-61. doi: 10.1016/j.ahj.2017.11.009. Epub 2017 Dec 5.

  PMID: 29447784 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sten Rubertsson, Md,PhD

  Uppsala Universtiy hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 5, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

SE (10); DK (3); NL (8)