NCT06587763

Brief Summary

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Study Progress8%
Oct 2025Dec 2032

First Submitted

Initial submission to the registry

June 18, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

June 18, 2024

Last Update Submit

June 23, 2025

Conditions

Cardiac Arrest, Out-Of-Hospital

Keywords

BiomarkersBrain injuryInflammationDementia

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Modified Rankin Scale 4-6

    6 months

Secondary Outcomes (2)

  • Neurocognitive outcomes

    6 months

  • Neurocognitive outcomes

    6 months

Eligibility Criteria

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

Adult patients with an out-of-hospital cardiac arrest who survived to six months follow-up

You may qualify if:

  • Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only

You may not qualify if:

  • Patients not participating in the extended follow-up at participating sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helsingborgs Hospital

Helsingborg, Sweden

Location

Skåne university hospital

Lund, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and PAX-RNA

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestBrain InjuriesInflammationDementia

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Marion Moseby-Knappe, MD, PhD

CONTACT

+46-46710000marion.moseby_knappe@med.lu.se

Niklas Nielsen, Prof

CONTACT

niklas.nielsen@med.lu.se

Study Design

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

Study Record Dates

First Submitted

June 18, 2024

First Posted

September 19, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2032

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

SE(3)