Out of Hospital Cardiac ArrestRAPID-MIRACLENCT05185063
Developing a Digital Handover Application for Paramedics to Provide a Personalized Approach to Pre-hospital Stratification for Out of Hospital Cardiac Arrest
An observational study of Out of Hospital Cardiac Arrest, run by King's College London.
Trial summary
A prospective study validating the role of the MIRACLE2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- Point of Care blood test
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community (i.e. pre-hospital study)
Who may be able to join
- Patients with out of hospital cardiac arrest with sustained ROSC (defined as >20 minutes or sufficient stability to consider conveyance)
Who cannot join
- Any clear non-cardiac cause of arrest (trauma, drowning Overdose, asphyxia, asthma, anaphylaxis).
- Suspected or confirmed intra-cerebral bleeding
- Known CPC score 3 or 4 pre-cardiac arrest
- Known disease limiting survival to 6 months
- Suspected or known pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
A prospective study validating the role of the MIRACLE2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting.
Read the detailed description
Design: Prospective observational cohort study enrolling OOHCA patients across London in a pre-hospital setting
Study Protocol: Patients with OOHCA and ROSC will be recruited from the community into the study by London Ambulance Service NHS Trust (LAS). LAS has -40 Advanced Paramedic Practitioners in Critical Care (APP-CC) who have a range of specialist skills including airway management and focused ultrasound and attend to over 1500 OOHCAs/year.
Point of Care pH test: The recruited participants will have point of care pH testing performed using the CG4+ iStat system (Abbott Vascular, Illinois, U.S.A.). The test requires 2ml of venous blood and can provide blood results within minutes. The device and blood taking system have received CE marking and are already in routine use across the NHS. Once the blood results are received, the blood sample and testing system are discarded in a routine manner.
Standard Care: Participants will then be conveyed to either the local emergency department or to a HAC based on current routine protocols. Patients will be treated in a routine manner after reaching secondary care in accordance with local and national guidance with no change in care based on this study.
Power calculation: In 2019, APP-CCs from LAS attended to -700 OOHCA patients with ROSC. Assuming 60% recruitment, we could comfortably envisage -500 patients to be recruited in a 15 month period. From previous data, we can expect approximately 60% of the patients (n=300) to have a CPC score of 3-5 on hospital discharge. This would be of a similar size to the dataset used to derive the original score, which gave good levels of accuracy in model performance measures.
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- Point of Care blood test
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care blood testDiagnostic test
The pH will be incorporated into the MIRACLE2 score in a pre-hospital setting. The patients will continue to be treated with standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Out of Hospital Cardiac Arrest | Not described Receives: Diagnostic Test: Point of Care blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Category at 30 days
Cerebral Performance Category
Measured: 40 dats
Secondary outcomes (5)
All cause mortality at 30 days
Death from any cause
Measured: 30 days
Cause of Death at 30 days
Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated
Measured: 30 days
Cerebral Performance Category at 6 months
Cerebral Performance Category
Measured: 6 months
All cause mortality at 6 months
Death from any cause
Measured: 6 months
Cause of Death at 6 months
Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- London Ambulance Service NHS Trust, King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nilesh Pareek, MA,MRCP,PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185063
- Sponsor's protocol ID
- 301864
- Acronym
- RAPID-MIRACLE
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Digital Handover Application for Paramedics to Provide a Personalized Approach to Pre-hospital Stratification for Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05185063
- Acronym / sponsor ID
- RAPID-MIRACLE / 301864
- Conditions
- Out of Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- London Ambulance Service NHS Trust, King's College Hospital NHS Trust
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study validating the role of the MIRACLE2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting.
Detailed description
Design: Prospective observational cohort study enrolling OOHCA patients across London in a pre-hospital setting
Study Protocol: Patients with OOHCA and ROSC will be recruited from the community into the study by London Ambulance Service NHS Trust (LAS). LAS has -40 Advanced Paramedic Practitioners in Critical Care (APP-CC) who have a range of specialist skills including airway management and focused ultrasound and attend to over 1500 OOHCAs/year.
Point of Care pH test: The recruited participants will have point of care pH testing performed using the CG4+ iStat system (Abbott Vascular, Illinois, U.S.A.). The test requires 2ml of venous blood and can provide blood results within minutes. The device and blood taking system have received CE marking and are already in routine use across the NHS. Once the blood results are received, the blood sample and testing system are discarded in a routine manner.
Standard Care: Participants will then be conveyed to either the local emergency department or to a HAC based on current routine protocols. Patients will be treated in a routine manner after reaching secondary care in accordance with local and national guidance with no change in care based on this study.
Power calculation: In 2019, APP-CCs from LAS attended to -700 OOHCA patients with ROSC. Assuming 60% recruitment, we could comfortably envisage -500 patients to be recruited in a 15 month period. From previous data, we can expect approximately 60% of the patients (n=300) to have a CPC score of 3-5 on hospital discharge. This would be of a similar size to the dataset used to derive the original score, which gave good levels of accuracy in model performance measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out of Hospital Cardiac Arrest | – | Diagnostic Test: Point of Care blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community (i.e. pre-hospital study)
Key inclusion criteria (1 listed)
- Patients with out of hospital cardiac arrest with sustained ROSC (defined as >20 minutes or sufficient stability to consider conveyance)
Key exclusion criteria (5 listed)
- Any clear non-cardiac cause of arrest (trauma, drowning Overdose, asphyxia, asthma, anaphylaxis).
- Suspected or confirmed intra-cerebral bleeding
- Known CPC score 3 or 4 pre-cardiac arrest
- Known disease limiting survival to 6 months
- Suspected or known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care blood testThe pH will be incorporated into the MIRACLE2 score in a pre-hospital setting. The patients will continue to be treated with standard of care. | Diagnostic test | Out of Hospital Cardiac Arrest |
Primary outcome
Cerebral Performance Category at 30 days
Time frame: 40 dats
Cerebral Performance Category
5 secondary outcomes
All cause mortality at 30 days
Time frame: 30 days
Cause of Death at 30 days
Time frame: 30 days
Cerebral Performance Category at 6 months
Time frame: 6 months
All cause mortality at 6 months
Time frame: 6 months
Cause of Death at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Heart Research United Kingdom - Novel Emerging Technology GrantLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Out of Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilesh Pareek, MA,MRCP,PhD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
An observational study of Out of Hospital Cardiac Arrest, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilesh Pareek, MA,MRCP,PhD (02032999000, nileshpareek@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Performance Category at 30 days (time frame: 40 dats). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.