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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 : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Out-of-Hospital Cardiac Arrest Procedure: Immediate coronary angiography Not Applicable

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 30 day survival [ Time Frame: 30 days ]
    Follow up will be performed at 30 days, telephone call or visit.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. Cardiac function [ Time Frame: 72 hours and at 6 months ]
    Measured with echocardiography

  5. 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.

  6. 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

  7. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sten Rubertsson Rubertsson, Md,PhD +46708693996 sten.rubertsson@akademiska.se
Contact: Stefan James, Md,PhD stefan.james@ucr.uu.se

Locations
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Sweden
Uppsala University hospital Recruiting
Uppsala, Sweden, 75185
Contact: Sten Rubertsson    +46708693996    sten.rubertsson@akademiska.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Sten Rubertsson, Md,PhD Uppsala Universtiy hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02309151     History of Changes
Other Study ID Numbers: DSC001
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases