- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02309151
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
Conditions
Intervention / Treatment
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
- Name: Sten Rubertsson Rubertsson, Md,PhD
- Phone Number: +46708693996
- Email: sten.rubertsson@akademiska.se
Study Contact Backup
- Name: Stefan James, Md,PhD
- Email: stefan.james@ucr.uu.se
Study Locations
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-
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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
-
-
-
-
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Amsterdam, Netherlands
- Recruiting
- Amsterdam UMC
-
Contact:
- José Henriques
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Dordrecht, Netherlands
- Recruiting
- Albert Schweitzer Hospital
-
Contact:
- Rohit Oemrawsingh
-
Eindhoven, Netherlands
- Recruiting
- Catharina Ziekenhuis
-
Contact:
- Luuk Otterspoor
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Emmen, Netherlands
- Recruiting
- Treant Hospital
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Contact:
- Rutger Anthonio
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Nieuwegein, Netherlands
- Recruiting
- Antonius hospital
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Contact:
- Jan-Peter Van Kuijk
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Nijmegen, Netherlands
- Recruiting
- Radboud University Medical Center
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Contact:
- Judith Bonnes
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The Hague, Netherlands
- Recruiting
- Haaglanden Medisch Centrum
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Contact:
- Dirk Van Der Heijden
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-
-
-
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Göteborg, Sweden
- Recruiting
- Sahlgrenska Universitetssjukhuset
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Contact:
- Peter Lundgren
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Huddinge, Sweden
- Recruiting
- Karolinska Universitetssjukhuset
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Contact:
- Liyew Desta
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Lund, Sweden
- Recruiting
- Skanes universitetssjukhus
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Contact:
- David Erlinge
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Solna, Sweden
- Recruiting
- Karolinska Universitetssjukhuset
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Contact:
- Liyew Desta
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Stockholm, Sweden
- Recruiting
- Södersjukhuset AB
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Contact:
- Ludig Elfwen
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Umeå, Sweden
- Recruiting
- Umeå Universitetssjukhus
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Contact:
- Peter Gottfridsson
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Uppsala, Sweden, 75185
- Recruiting
- Uppsala University Hospital
-
Contact:
- Sten Rubertsson
- Phone Number: +46708693996
- Email: sten.rubertsson@akademiska.se
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Örebro, Sweden
- Recruiting
- Örebro Universitetssjukhus
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Contact:
- Anna Matsson
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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
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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
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Cardiac function
Time Frame: 72 hours and at 6 months
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Measured with echocardiography
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72 hours and at 6 months
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Follow up of neurological function at 6-months
Time Frame: Measured at 6 months
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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.
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Measured at 6 months
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Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)
Time Frame: During ICU care (maximum of 7 days)
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Parameters measured daily during ICU care
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During ICU care (maximum of 7 days)
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ECG findings compared to findings at coronary angiography
Time Frame: During hospital stay up to a maximum of 6-months
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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)
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During hospital stay up to a maximum of 6-months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
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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