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Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS) (PCAS)

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ClinicalTrials.gov Identifier: NCT02664831
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
David B. Seder MD, MaineHealth

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
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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS)
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 20, 2026
Estimated Study Completion Date : March 20, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlations between inflammatory markers and clinical outcomes [ Time Frame: 14 days ]
    Correlations between inflammatory markers and clinical outcomes

  2. Correlations between inflammatory markers and biomarkers of neurological and cardiac injury [ Time Frame: 7 days ]
    Correlations between inflammatory markers and biomarkers of neurological and cardiac injury


Secondary Outcome Measures :
  1. Characterization of post-resuscitation inflammatory mechanisms and their regulators [ Time Frame: 7 days ]
    Characterization of post-resuscitation inflammatory mechanisms and their regulators


Biospecimen Retention:   Samples Without DNA
Whole blood will be assayed for cellular components, neuregulin, ERBB receptors, proteins and lipids


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac arrest survivors with encephalopathy admitted to the intensive care unit and unresponsive after resuscitation
Criteria

Inclusion Criteria:

  • Survival >48 hours anticipated
  • Informed consent from medicolegal POA within 24 hours of resuscitation

Exclusion Criteria:

  • Not anticipated to survive at least 48 hours
  • Hemoglobin < 7 g/dL or requiring transfusion
  • Hemoglobin < 9 g/dL in pregnant subjects
  • No available medicolegal POA or refuses consent
  • Research team unavailable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664831


Contacts
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Contact: David B Seder, MD 207-662-2179 sederd@mmc.org
Contact: David Gagnon, PharmD 207-662-1338 DGagnon@mmc.org

Locations
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United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: David B Seder, MD    207-662-2179    sederd@mmc.org   
Contact: Sergey Ryzhov, MD, PhD       SRyzhov@mmc.org   
Sub-Investigator: David Gagnon, PharmD         
Sponsors and Collaborators
MaineHealth
Investigators
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Study Chair: Sergey Ryzhov, MD, PhD MaineHealth
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Responsible Party: David B. Seder MD, Chief, Department of Critical Care, Associate Professor of Medicine, MaineHealth
ClinicalTrials.gov Identifier: NCT02664831    
Other Study ID Numbers: DBS1
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Keywords provided by David B. Seder MD, MaineHealth:
cardiac arrest
inflammation
immune
neuregulin
lymphocyte
Additional relevant MeSH terms:
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Post-Cardiac Arrest Syndrome
Heart Arrest
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Reperfusion Injury
Vascular Diseases
Postoperative Complications