NCT05185063

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

December 23, 2021

Last Update Submit

December 23, 2021

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Cerebral Performance Category at 30 days

    Cerebral Performance Category

    40 dats

Secondary Outcomes (5)

  • All cause mortality at 30 days

    30 days

  • Cause of Death at 30 days

    30 days

  • Cerebral Performance Category at 6 months

    6 months

  • All cause mortality at 6 months

    6 months

  • Cause of Death at 6 months

    6 months

Study Arms (1)

Out of Hospital Cardiac Arrest

Diagnostic Test: Point of Care blood test

Interventions

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.

Out of Hospital Cardiac Arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community (i.e. pre-hospital study)

You may qualify if:

  • Patients with out of hospital cardiac arrest with sustained ROSC (defined as \>20 minutes or sufficient stability to consider conveyance)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Nilesh Pareek, MA,MRCP,PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilesh Pareek, MA,MRCP,PhD

CONTACT

02032999000nileshpareek@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 11, 2022

Study Start

March 1, 2022

Primary Completion

June 30, 2023

Study Completion

March 1, 2024

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share