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

NCT ID: NCT02309151

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Out-of-Hospital Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate coronary angiography

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

Group Type EXPERIMENTAL

Immediate coronary angiography

Intervention Type PROCEDURE

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

Not immediate coronary angiography

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immediate coronary angiography

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sten Rubertsson, Md,PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala Universtiy hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aalborg University hospital

Aalborg, , Denmark

Site Status TERMINATED

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Odense University hospital

Odense, , Denmark

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Albert Schweitzer Hospital

Dordrecht, , Netherlands

Site Status RECRUITING

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status RECRUITING

Treant Hospital

Emmen, , Netherlands

Site Status RECRUITING

Zuyderland Hospital

Heerlen, , Netherlands

Site Status RECRUITING

Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status RECRUITING

Karolinska Universitetssjukhuset

Huddinge, , Sweden

Site Status TERMINATED

Skånes Universitetssjukhus

Lund, , Sweden

Site Status TERMINATED

Skåne Universitetssjukhus

Malmo, , Sweden

Site Status TERMINATED

Örebro Universitetssjukhus

Örebro, , Sweden

Site Status TERMINATED

Karolinska Universitetssjukhuset

Solna, , Sweden

Site Status RECRUITING

Danderyd Sjukhus

Stockholm, , Sweden

Site Status TERMINATED

Södersjukhuset AB

Stockholm, , Sweden

Site Status RECRUITING

Umeå Universitetssjukhus

Umeå, , Sweden

Site Status RECRUITING

Uppsala University hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark Netherlands Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sten Rubertsson Rubertsson, Md,PhD

Role: CONTACT

+46708693996

Stefan James, Md,PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christian Juhl Terkelsen

Role: primary

Lisette Okkels Jensen

Role: primary

José Henriques

Role: primary

Rohit Oemrawsingh

Role: primary

Luuk Otterspoor

Role: primary

Rutger Anthonio

Role: primary

R van der Vleugel

Role: primary

Jan-Peter Van Kuijk

Role: primary

Judith Bonnes

Role: primary

Dirk Van Der Heijden

Role: primary

Peter Lundgren

Role: primary

Liyew Desta

Role: primary

Ludig Elfwen

Role: primary

Peter Gottfridsson

Role: primary

Sten Rubertsson

Role: primary

+46708693996

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32154359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31028826 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29447784 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSC001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Delayed Postconditioning
NCT01483755 COMPLETED PHASE2