Clinical Trial: Direct or Subacute Coronary Angiography for Out-of-hospital Cardiac Arrest

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Direct or Subacute Coronary Angiography for Out-of-hospital Cardiac Arrest - a Randomized Study

Brief Summary: The overall aim of this prospective, randomized pilot study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, is safe to implement in patients with out of hospital cardiac arrest. The primary question at issue is whether early angiography (within 120 minutes) with a predefined strategy for revascularization with percutaneous coronary intervention (PCI) is safe to carry out in this group of patients. The patients randomized to acute coronary angiography will be compared with a control group who will be treated according to standard practice with coronary angiography with possible subsequent intervention according to the current routine, which usually does not occur within the first three days after cardiac arrest.

Detailed Summary: The study is an open prospective randomized multicenter study with a registry follow up where out of hospital cardiac arrest without ST-elevation myocardial infarction (STEMI) in ECG will be randomized to direct coronary angiography with possible intervention or the usual care without acute coronary angiography. The study will include 120 patients in total , of which 80 patients without STEMI and 40 patients with STEMI after successful resuscitation after cardiac arrest. Randomization takes place immediately after ECG is taken in conjunction with the first medical contact. First ECG can be taken to the emergency room if the prehospital situation for various reasons do not permit or enable ECG recording. Randomization will then occur in the emergency room. Coronary angiography should be done within 120 minutes from first medical contact in the treatment group. Randomization will be done via a web based module.The group without STEMI whom will not be randomized to acute coronary angiography will be treated according to standard practice where coronary angiography with possible following intervention is up to the competent cardiologist.The strategy is avoid coronary angiography during the first 3 days unless urgent indication occurs during the care process such as renewed chest pain, renewed STEMI circulatory instability or cardiogenic shock. This is also the standard method currently practiced in Swedish and international hospitals. The group with STEMI on the first ECG is logged and followed, and the patients in this group are studied separately in order to describe and evaluate the frequency of acute intervention in this group and look at the survival data compared with the study population and against an unselected STEMI material without cardiac arrest.
Sponsor: Uppsala University

Current Primary Outcome:

• 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
  
  

  Original Primary Outcome:

  • 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
    
    

    Current Secondary Outcome:

    • 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,Informant questionnaire code (IQ code) and Montreal cognitive assessment (MoCA),Mini mental state examination (MMSE), Hospital anxiey and depression scale(HADS), Multidimensional Fatigue inventory (MFI-20) and the Somatic Health Complaints Questionnaire (SHCQ).
    • 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.
    
    
    

    Original Secondary Outcome:

    • 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.
    
    
    Information By: Uppsala University
    

    Dates:
    Date Received: November 17, 2014
    Date Started: December 2014
    Date Completion: March 2017
    Last Updated: October 26, 2016
    Last Verified: October 2016