An observational study in Cardiac Arrest, Inflammation and Obesity, sponsored by MaineHealth. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by MaineHealth · Observational
This is a prospective, observational study to investigate molecular mechanisms mediating the systemic inflammatory process, and changes to metabolism, and their impact on brain injury, survival, and functional outcomes after cardiac arrest. Investigators have shown that cardiac arrest induces changes in the numbers and properties of circulating immune cells, shifting the balance towards a pro-inflammatory phenotype and there is increased interest in the inflammatory pathways and the signaling mechanisms through which they are modulated. Participants will undergo blood sampling during 7 days following cardiac arrest, and analyses performed. Patient characteristics, clinical circumstances, and outcomes will be recorded and their associations with these inflammatory pathways characterized.
Preliminary evidence indicates that inter-individual variables such as immune cell activity and the production of pro-inflammatory factors may differentiate patients with the highest risk of poor neurological outcome, and may reveal novel therapeutic approaches based on promoting molecular pathways of inflammation-resolution and recovery to reduce the severity of hypoxic ischemic encephalopathy (HIE). Additionally, there are intrinsic, modifiable metabolic factors, such as the presence and metabolic activity of brown adipose tissue (BAT) that may modulate injury and recovery.
Comparative analysis showed that cardiac arrest survivors have more CD73+ lymphocytes compared to non-survivors. CD73 is the key enzyme in the generation of anti-inflammatory and immunosuppressive adenosine. We have also identified novel populations of neutrophils (CD14posCD16low and DEspR+) that had amplified response to inflammatory stimuli. The investigators hypothesize that individual variability in the expression and signaling profiles of white blood cells (lymphocytes, neutrophils, monocytes and macrophages) following resuscitation affects inflammation and is independently associated with neurological outcome. To test this hypothesis, investigators will determine levels of various immune cell populations at different time points in peripheral blood of patients. Characterization of blood circulating factors, clinical phenotypes, and neurological outcomes after cardiac arrest is a second aim of this project, with a focus on understanding the heterogeneity of cellular and humoral immune responses and how they relate to different clinical phenotypes of post-resuscitation syndrome.
PCAS metabolism:
IT is known that hyperglycemia is an independent risk factor for poor outcome after cardiac arrest, but it is not known if modification of hyperglycemia reduces this risk. Published studies have not demonstrated benefit with intensive insulin therapy. Our preliminary data suggest correlation between brown adipose tissue activity and good outcome. We have postulated that BAT may be activated by therapeutic hypothermia and may act as a glucose sink reducing the oxidative stress caused by hyperglycemia, and secondarily reducing injury to the brain, heart, and other organs.
In these studies we will also investigate other actionable targets for new therapies.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 376 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cardiac arrest survivors with encephalopathy admitted to the intensive care unit and unresponsive after resuscitation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Correlations between inflammatory markers and clinical outcomes
Correlations between inflammatory markers and clinical outcomes
Time frame: 14 days
Correlations between inflammatory markers and biomarkers of neurological and cardiac injury
Correlations between inflammatory markers and biomarkers of neurological and cardiac injury
Time frame: 7 days
Characterization of post-resuscitation inflammatory mechanisms and their regulators
Characterization of post-resuscitation inflammatory mechanisms and their regulators
Time frame: 7 days
Brown Fat activity
Correlations between 12,13 diHOME, blood glucose, and outcome
Time frame: 2 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in any publications, after deidentification.
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 6 months following article publication
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee.
Data sharing details ↗ · www.mainehealth.org
Started Jan 2016 (actual). Primary completion is estimated for Jan 2027, 132 months after the start.
Of 169 non-industry observational studies under Heart Arrest, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 90. This study's planned 132 months is above that.
Counting every sponsor, half of 176 studies reached it within 41 months; a quarter within 18 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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