Cardiac Arrest (CA)NCT07017374
Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy
An observational study of Cardiac Arrest (CA) and Proteomics, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Proteomics
- What is being tested?
- Proteomic analysis, targeted temperature management
- How many people
- 682 participants
- Where
- 1 siteSweden
- Study dates
- 22 May 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with an out-of-hospital cardiac arrest with presumed cardiac cause.
Inclusion Criteria as defined in the TTM trial (NCT01020916):
- 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
Exclusion Criteria as defined in the TTM trial (NCT01020916):
- 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
- Systolic blood pressure < 80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump. If the systolic blood pressure (SBP) is recovering during the inclusion window (220 minutes) the patient can be included.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background: A pilot study investigating proteomic profiles from 78 patients from the Target Temperature Management after Out-of-hospital Cardiac arrest (TTM) trial revealed 35 proteins associated to functional outcome, and six proteins associated to targeted temperature management at 33 °C. We plan to investigate proteomic profiles in the full cohort of the previously collected TTM-trial biobank. The aim is to stratify protein profiles based on survival, functional outcome, targeted temperature management, and MIRACLE2 score in order to search for potential novel biomarkers, therapeutic targets, and to explore phenotypes of post-cardiac arrest syndrome.
Methods: All patients with available serum samples at 24, 48, and/or 72 hours after return of spontaneous circulation will be included in the liquid chromatography and tandem mass spectrometry analysis using diaPASEF, combining data-independent-acquisition of spectra with parallel accumulation-serial fragmentation. Statistical analysis will include data normalisation, exploratory principal component analysis, and differential expression analysis. Changes in serum protein abundance will be analysed according to survival and binary functional outcome (modified Rankin Scale 0-3 vs. 4-6) at six-months after randomisation, randomisation to target temperature of 33 °C or 36 °C, and the MIRACLE2 score. Secondary stratifications will include sex, age, time to return of spontaneous circulation, shockable vs. non-shockable initial rhythm, circulatory shock on admission, and presumed cause of death.
Conclusion: This study will provide information about proteomic profiles after cardiac arrest and may give insight for identification of novel biomarkers for prediction of outcome.
- Conditions
- Cardiac Arrest (CA), Proteomics
- Being tested
- Proteomic analysis, targeted temperature management
- Keywords
- out-of-hospital cardiac arrest, heart arrest, proteomics, prognostication, hypothermic temperature control, targeted temperature management
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic analysis, targeted temperature managementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start22 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niklas Nielsen, Professor, MD, Principal investigator, Lund University, Helsingborg hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017374
- Sponsor's protocol ID
- 2009/324
- Status last verified
- Apr 2026
- First submitted
- 22 May 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The acquired mass spectrometry data, result files from peptide-centric analyses, spectral libraries, and other metadata will be deposited to the ProteomeXchange Consortium and made publicly available.
Publications
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.
PubMed 22520518Lileikyte 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.
PubMed 37455296Nielsen 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.
PubMed 24237006
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy
- ClinicalTrials.gov ID
- NCT07017374
- Acronym / sponsor ID
- 2009/324
- Conditions
- Cardiac Arrest (CA), Proteomics
- Keywords
- out-of-hospital cardiac arrest, heart arrest, proteomics, prognostication, hypothermic temperature control, targeted temperature management
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (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.
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.
Detailed description
Background: A pilot study investigating proteomic profiles from 78 patients from the Target Temperature Management after Out-of-hospital Cardiac arrest (TTM) trial revealed 35 proteins associated to functional outcome, and six proteins associated to targeted temperature management at 33 °C. We plan to investigate proteomic profiles in the full cohort of the previously collected TTM-trial biobank. The aim is to stratify protein profiles based on survival, functional outcome, targeted temperature management, and MIRACLE2 score in order to search for potential novel biomarkers, therapeutic targets, and to explore phenotypes of post-cardiac arrest syndrome.
Methods: All patients with available serum samples at 24, 48, and/or 72 hours after return of spontaneous circulation will be included in the liquid chromatography and tandem mass spectrometry analysis using diaPASEF, combining data-independent-acquisition of spectra with parallel accumulation-serial fragmentation. Statistical analysis will include data normalisation, exploratory principal component analysis, and differential expression analysis. Changes in serum protein abundance will be analysed according to survival and binary functional outcome (modified Rankin Scale 0-3 vs. 4-6) at six-months after randomisation, randomisation to target temperature of 33 °C or 36 °C, and the MIRACLE2 score. Secondary stratifications will include sex, age, time to return of spontaneous circulation, shockable vs. non-shockable initial rhythm, circulatory shock on admission, and presumed cause of death.
Conclusion: This study will provide information about proteomic profiles after cardiac arrest and may give insight for identification of novel biomarkers for prediction of outcome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an out-of-hospital cardiac arrest with presumed cardiac cause.
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 |
|---|---|---|
| Proteomic analysis, targeted temperature managementBiobank 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. | Other | – |
Primary outcome
Differential protein abundance
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 22520518Nielsen 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.
- Background: PubMed 37455296Lileikyte 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.
- Background: PubMed 24237006Nielsen 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.
- Individual participant dataSharing planned: Yes. The acquired mass spectrometry data, result files from peptide-centric analyses, spectral libraries, and other metadata will be deposited to the ProteomeXchange Consortium and made publicly available.
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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.
Niklas Nielsen, Professor, MD principal investigator
Lund University, Helsingborg hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA) and Proteomics, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential protein abundance (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017374, which also lists 3 linked publications.
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 28 Apr 2026.