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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309151
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date  ICMJE November 17, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
30 day survival [ Time Frame: 30 days ]
Follow up will be performed at 30 days, telephone call or visit.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • Care deviations (All deviations that may affect the patients safety during prehospital and hospital care) [ Time Frame: From study start to discharge from hospital, an average stay of 4 weeks ]
    All deviations that may affect the patients safety during prehospital and hospital care will be reported at a prehospital and hospital stage will be reported according to the usual deviation system.
  • Prehospital timeframes [ Time Frame: From study start to admission to hospital an average timeframe of 1 hour ]
    Prehospital times, any delay from first contact to arrival at hospital
  • Logistics (Logistics problems associated with randomization / inclusion) [ Time Frame: From study start to randomization, an expected average of 1 hour ]
    Logistics problems associated with randomization / inclusion
  • Prognostic factors (blood acidity (pH, lactate), oxygen saturation (PaO2), blood sugar level, electrolytes) [ Time Frame: 6 months ]
    Possible differences in prognostic factors on arrival at the hospital (emergency department and intensive care unit) as blood acidity (pH, lactate), oxygen saturation (PaO2), blood sugar level, electrolytes.
  • Monitoring of circulation [ Time Frame: From admission to ICU to discharge from ICU, an expected average of 1 week ]
    Monitoring of circulation the first 72 hours at the intensive care unit
  • Supportive care (differences in need of supportive care in terms of circulation with drugs (inotropes) and mechanical devices) [ Time Frame: From admission to ICU to discharge from ICU.an expected average of 1 week ]
    Any differences in need of supportive care in terms of circulation with drugs (inotropes) and mechanical devices (intra-aortic balloon pump, extra corporal circulation - ECMO)
  • Cardiac assessment (Echo, biochemical markers) [ Time Frame: 6 months ]
    Assessment of Cardiac Function (Echo, biochemical markers)
  • Delay to standard treatment [ Time Frame: From study start to admission to ICU,from 1-5 hours ]
    Identify any problems / delays associated with coronary angiography as the delay to other accepted treatment in the ICU as cooling (hypothermia) and support of the circulation and respiration.
  • Study events (serious adverse events) [ Time Frame: 6 months ]
    Be able to monitor all serious adverse events (complications) that may be associated with acute coronary angiography and percutaneous coronary intervention (PCI) such as bleeding, coronary vessel dissection, new thrombosis of coronary arteries and procedure-related cardiac arrest (ventricular fibrillation and PEA / asystole.) These parameters are monitored in the Swedish coronary angiographic and angioplastic registry (SCAAR).
  • Health economics (Length of stay ) [ Time Frame: 1-2 years ]
    Length of stay in hospital including ICU care. These timeframes should be reported clearly at each care unit stating any extended time.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • Survival [ Time Frame: 6 months ]
    30-day survival. Survival with good neurological function according to the Cerebral performance category scale (CPC)and modified rankin scale (mRS), at 30 days. Survival at discharge from ICU . Survival with good neurological function according to the CPC and mRS at discharge from ICU. Survival at discharge from hospital. Survival with good neurological function according to the CPC and mRS at discharge from hospital. Survival at 6 months.Survival with good neurological function according to the CPC and mRS at 6 months
  • Cardiac function (left ventricular function) [ Time Frame: 6 months ]
    Cardiac function (left ventricular function) measured by echo at 72 hours and after 6 months.
  • ECG findings (ie How often is ischemic signs missing in first ECG but changes in the coronary arteries can be seen at coronary angiography post resuscitation after cardiac arrest) [ Time Frame: From study start to discharge from ICU, an expected average of 4 weeks ]
    ECG findings associated with angiographic findings (ie How often is ischemic signs missing in first ECG but changes in the coronary arteries can be seen at coronary angiography post resuscitation after cardiac arrest)
  • Neurologic function [ Time Frame: 6 months ]
    A 6 month follow-up of neurologic function will be assessed by Cerebral performance category(CPC), Modified rankin scale (mRS), Two simple questions,Intelligence quote code (IQ code) and Montreal cognitive assessment (MoCA)
  • Hemodynamic measures (measured by Vigileo or equivalent method) [ Time Frame: From study start to discharge from ICU an expected average of 4 weeks ]
    Hemodynamic parameters (measured by Vigileo or equivalent method) during the time at ICU as cardiac index and the need for inotropic / vasopressor drugs and ECHO (within 6 hours) and after 24 hours.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest
Official Title  ICMJE Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Out-of-Hospital Cardiac Arrest
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Immediate coronary angiography
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
1006
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2014)
120
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sten Rubertsson Rubertsson, Md,PhD +46708693996 sten.rubertsson@akademiska.se
Contact: Stefan James, Md,PhD stefan.james@ucr.uu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02309151
Other Study ID Numbers  ICMJE DSC001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sten Rubertsson, Md,PhD Uppsala Universtiy hospital
PRS Account Uppsala University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP