The RAPID-MIRACLE Study

• Research type

  Research Study

• Full title

  Developing a digital handover application for paramedics to provide a personalized approach to pre-hospital stratification for OOHCA – the RAPID-MIRACLE study

• IRAS ID

  301864

• Contact name

  Nilesh Pareek

• Contact email

  nileshpareek@nhs.net

• Sponsor organisation

  Director of Research Management & Director of Administration (Health Schools),

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This study aims to improve how we care for patients who suffer a medical condition where the heart stops in the community called “cardiac arrest” (Out of Hospital Cardiac Arrest - OOHCA). This study is a prospective study and its
  purpose is to identify patients admitted with cardiac arrest who are most likely to survive with good outcome. This could improve how we treat patients with this condition in the future.
  In particular, our research study will aim to understand which patients are at highest risk of severe brain damage after OOHCA. The study has only one research step which is when we take 2ml of venous blood for point of care testing at the time of recovery from the cardiac arrest. This step is for research only and is not part of routine care. The study will validate a previously developed risk score called the MIRACLE2 risk score. Patients will then be followed up at 30 days and 6 months to evaluate their outcome. Information from their pre-hospital medical records will be collected by research paramedics from London Ambulance Service NHS Trust and after hospital data by the clinical research fellow at King's College Hospital NHS Foundation Trust.

  Data from the hospital will be accessed by the direct care team at the sites initially. These will then be shared with the clinical research fellow at KCH through safe mechanisms (nhs.net). Consent, declaration of consultee approval or CAG approval would be sought in all cases before the data is accessed.

  Once this data is obtained, we will perform statistical analyses (called reciver oprating characteristic ROC curves) to understand how well the MIRACLE2 can predict poor outcome at 30 days (defined by a classification called the cerebral performance category 3-5) when applied in a pre-hospital setting.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  22/EE/0001

• Date of REC Opinion

  2 Mar 2022

• REC opinion

  Further Information Favourable Opinion