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

December 21, 2023 updated by: Uppsala University

Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study

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.

Study Overview

Status

Recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

1006

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Aalborg, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Philip Freeman
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Christian Juhl Terkelsen
      • Odense, Denmark
        • Recruiting
        • Odense University Hospital
        • Contact:
          • Lisette Okkels Jensen
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC
        • Contact:
          • José Henriques
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweitzer Hospital
        • Contact:
          • Rohit Oemrawsingh
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina Ziekenhuis
        • Contact:
          • Luuk Otterspoor
      • Emmen, Netherlands
        • Recruiting
        • Treant Hospital
        • Contact:
          • Rutger Anthonio
      • Nieuwegein, Netherlands
        • Recruiting
        • Antonius hospital
        • Contact:
          • Jan-Peter Van Kuijk
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud University Medical Center
        • Contact:
          • Judith Bonnes
      • The Hague, Netherlands
        • Recruiting
        • Haaglanden Medisch Centrum
        • Contact:
          • Dirk Van Der Heijden
      • Göteborg, Sweden
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Peter Lundgren
      • Huddinge, Sweden
        • Recruiting
        • Karolinska Universitetssjukhuset
        • Contact:
          • Liyew Desta
      • Lund, Sweden
        • Recruiting
        • Skanes universitetssjukhus
        • Contact:
          • David Erlinge
      • Solna, Sweden
        • Recruiting
        • Karolinska Universitetssjukhuset
        • Contact:
          • Liyew Desta
      • Stockholm, Sweden
        • Recruiting
        • Södersjukhuset AB
        • Contact:
          • Ludig Elfwen
      • Umeå, Sweden
        • Recruiting
        • Umeå Universitetssjukhus
        • Contact:
          • Peter Gottfridsson
      • Uppsala, Sweden, 75185
      • Örebro, Sweden
        • Recruiting
        • Örebro Universitetssjukhus
        • Contact:
          • Anna Matsson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day survival
Time Frame: 30 days
Follow up will be performed at 30 days, telephone call or visit.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival with good neurological function
Time Frame: 30 days
30-day survival and a follow up of health status, functional outcome associated to cerebral performance and general functional outcome/activities of daily living
30 days
Survival at discharge from ICU (individual for each subject) and at 6-months
Time Frame: At discharge from ICU, an expected average of 3-30 days and at 6-months
Recorded in the e-CRF (electronic Case Report Form)
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
Time Frame: At discharge from ICU, an expected average of 3-30 days and at 6-months
Survival with good neurological function at discharge and at 6-months. Assessing functional outcome associated to cerebral performance and general functional outcome/activities of daily living and also global functional outcome, independent living and social reintegration at 6-months
At discharge from ICU, an expected average of 3-30 days and at 6-months
Cardiac function
Time Frame: 72 hours and at 6 months
Measured with echocardiography
72 hours and at 6 months
Follow up of neurological function at 6-months
Time Frame: Measured at 6 months
A 6 month follow up of neurological function will be assessed by validated screening battery in OHCA (Out of Hospital Cardiac Arrest) patients in general functional outcome, activities of daily living, cognitive functioning, attention, anxiety and depression, fatigue, cardiac disease specific health and care giver burden.
Measured at 6 months
Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)
Time Frame: During ICU care (maximum of 7 days)
Parameters measured daily during ICU care
During ICU care (maximum of 7 days)
ECG findings compared to findings at coronary angiography
Time Frame: During hospital stay up to a maximum of 6-months
Primary ECG, performed in the pre-hospital setting or at the emergency department, will be compared with findings at coronary angiography intervention (performed immediately or later during hospital stay depending on randomisation)
During hospital stay up to a maximum of 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sten Rubertsson, Md,PhD, Uppsala Universtiy hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimated)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DSC001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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