Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy

NCT07017374 | Active Not Recruiting

• 1 other identifier: 2009/324
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac arrest remains a large contributor to morbidity and mortality. Animal studies suggest an improvement in mortality and neurological function with hypothermia after cardiac arrest, a finding that could not be verified in large clinical trials such as Target Temperature Management after Out-of-hospital Cardiac arrest (TTM) trial. Multimodal neuroprognostication is an important tool for differentiating patients that will recover after cardiac arrest, and currently only one biomarker is in clinical use. The purpose of this study is to explore proteomics profiles in TTM trial patients in order to search for potential novel biomarkers, therapeutic targets, and to explore phenotypes of post-cardiac arrest syndrome.

Conditions

Cardiac Arrest (CA); Proteomics

Keywords

out-of-hospital cardiac arrest; heart arrest; proteomics; prognostication; hypothermic temperature control; targeted temperature management

Outcome Measures

Primary Outcomes (1)

• Differential protein abundance

  Differential protein abundance will be acquired using proteomic analysis of serum samples. Protein abundance will be stratified in statistical analysis according to pre-specified clinical outcomes.

  Differential protein abundance is evaluated 24, 48, and/or 72 hours after return of spontaneous circulation after cardiac arrest. Clinical outcomes are evaluated 180 days after cardiac arrest.

Interventions

Proteomic analysis, targeted temperature management OTHER

Biobank serum samples from patients that were included in the TTM trial will be used for proteomic analysis. TTM trial randomised patients to targeted temperature management of 33 °C or 36 °C.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with an out-of-hospital cardiac arrest with presumed cardiac cause.

You may qualify if:

• Age ≥ 18 years old
• Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause
• Return of spontaneous circulation (ROSC)
• Unconsciousness (Glasgow Coma Score \< 8) (patients not able to obey verbal commands) after sustained ROSC

You may not qualify if:

• In-hospital cardiac arrest
• OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
• Known bleeding diathesis (medically induced coagulopathy (e.g warfarin, clopidogrel) does not exclude the patient).
• Suspected or confirmed acute intracranial bleeding
• Suspected or confirmed acute stroke
• Unwitnessed asystole
• Known limitations in therapy and Do Not Resuscitate-order
• Known disease making 180 days survival unlikely
• Known pre-arrest CPC 3 or 4
• Temperature \< 30°C on admission
• \> 4 hours (240 minutes) from ROSC to screening

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Lund University

Lund, Skåne County, 22362, Sweden

Location

Related Publications (3)

• Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langorgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thoren A, Unden J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.

  PMID: 22520518 BACKGROUND

• Lileikyte G, Bakochi A, Ali A, Moseby-Knappe M, Cronberg T, Friberg H, Lilja G, Levin H, Arman F, Kjellstrom S, Dankiewicz J, Hassager C, Malmstrom J, Nielsen N. Serum proteome profiles in patients treated with targeted temperature management after out-of-hospital cardiac arrest. Intensive Care Med Exp. 2023 Jul 17;11(1):43. doi: 10.1186/s40635-023-00528-0.

  PMID: 37455296 BACKGROUND

• Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

  PMID: 24237006 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Niklas Nielsen, Professor, MD

  Lund University, Helsingborg hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 12, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Publicly available

Locations

SE (1)