Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest (DISCO)
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ClinicalTrials.gov Identifier: NCT02309151 |
Recruitment Status :
Recruiting
First Posted : December 5, 2014
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Out-of-Hospital Cardiac Arrest | Procedure: Immediate coronary angiography | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1006 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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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
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Procedure: 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 |
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.
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- 30 day survival [ Time Frame: 30 days ]Follow up will be performed at 30 days, telephone call or visit.
- 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
- 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)
- 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
- Cardiac function [ Time Frame: 72 hours and at 6 months ]Measured with echocardiography
- 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.
- 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
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309151
Contact: Sten Rubertsson Rubertsson, Md,PhD | +46708693996 | sten.rubertsson@akademiska.se | |
Contact: Stefan James, Md,PhD | stefan.james@ucr.uu.se |
Sweden | |
Uppsala University hospital | Recruiting |
Uppsala, Sweden, 75185 | |
Contact: Sten Rubertsson +46708693996 sten.rubertsson@akademiska.se |
Principal Investigator: | Sten Rubertsson, Md,PhD | Uppsala Universtiy hospital |
Responsible Party: | Uppsala University |
ClinicalTrials.gov Identifier: | NCT02309151 |
Other Study ID Numbers: |
DSC001 |
First Posted: | December 5, 2014 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Arrest Out-of-Hospital Cardiac Arrest Heart Diseases Cardiovascular Diseases |