Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS)

Sponsor

MaineHealth (Other)

Overall Status

Recruiting

CT.gov ID

NCT02664831

Collaborator

(none)

240

Enrollment

Location

122.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, observational study to investigate molecular mechanisms mediating the systemic inflammatory process, 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Inflammation Obesity

Detailed Description

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 outcomes, and may reveal novel therapeutic approaches based on promoting molecular pathways of inflammation-resolution 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS)

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 20, 2026

Anticipated Study Completion Date :

Mar 20, 2026

Outcome Measures

Primary Outcome Measures

Correlations between inflammatory markers and clinical outcomes [14 days]
Correlations between inflammatory markers and clinical outcomes
Correlations between inflammatory markers and biomarkers of neurological and cardiac injury [7 days]
Correlations between inflammatory markers and biomarkers of neurological and cardiac injury

Secondary Outcome Measures

Characterization of post-resuscitation inflammatory mechanisms and their regulators [7 days]
Characterization of post-resuscitation inflammatory mechanisms and their regulators