Clinical trial NCT02309151: Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest
Official title: Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-of-Hospital Cardiac Arrest
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 inclusion and randomization at hospital

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)

Primary outcomes:
measure: 30 day survival
timeFrame: 30 days
Secondary outcomes:
measure: Survival with good neurological function
timeFrame: 30 days
measure: Survival at discharge from ICU (individual for each subject) and at 6-months
timeFrame: At discharge from ICU, an expected average of 3-30 days and at 6-months
measure: Survival with good neurological function at discharge from ICU and 6-months
timeFrame: At discharge from ICU, an expected average of 3-30 days and at 6-months
measure: Cardiac function
timeFrame: 72 hours and at 6 months
measure: Follow up of neurological function at 6-months
timeFrame: Measured at 6 months
measure: Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)
timeFrame: During ICU care (maximum of 7 days)
measure: ECG findings compared to findings at coronary angiography
timeFrame: During hospital stay up to a maximum of 6-months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Emmen
country: Netherlands
facility: Treant Hospital
city: Heerlen
country: Netherlands
facility: Zuyderland Hospital
city: Nieuwegein
country: Netherlands
facility: Antonius Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: The Hague
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus
city: Malmö
country: Sweden
facility: Skåne Universitetssjukhus
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Danderyd Sjukhus
city: Stockholm
country: Sweden
facility: Södersjukhuset AB
city: Umeå
country: Sweden
facility: Umeå Universitetssjukhus
city: Uppsala
country: Sweden
facility: Uppsala University hospital
city: Örebro
country: Sweden
facility: Örebro Universitetssjukhus
Study officials:
affiliation: Uppsala Universtiy hospital
name: Sten Rubertsson, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.