Immunoinflammatory Response in Post Cardiac Arrest Syndrome (PCAS)

NCT02664831 | Recruiting

• 2 other identifiers: DBS11P20GM139745-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest; Inflammation; Obesity; Hypoxic Ischemic Encephalopathy (HIE)

Keywords

cardiac arrest; inflammation; immune; neuregulin; lymphocyte; neutrophil; brown adipose; HIE

Outcome Measures

Primary Outcomes (2)

• Correlations between inflammatory markers and clinical outcomes

  Correlations between inflammatory markers and clinical outcomes

  14 days

• Correlations between inflammatory markers and biomarkers of neurological and cardiac injury

  Correlations between inflammatory markers and biomarkers of neurological and cardiac injury

  7 days

Secondary Outcomes (2)

• Characterization of post-resuscitation inflammatory mechanisms and their regulators

  7 days

• Brown Fat activity

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac arrest survivors with encephalopathy admitted to the intensive care unit and unresponsive after resuscitation

You may qualify if:

• Aged 18 years or older
• Admitted to the intensive care unit after cardiac arrest episode
• Unresponsive after resuscitation

You may not qualify if:

• Moribund / actively dying at the time of evaluation
• Informed consent cannot be obtained within 24 hours of resuscitation
• Hemoglobin less than 7.0 g/dL, active high-volume bleeding, or requiring a transfusion

Sponsors & Collaborators

• MaineHealth: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

Related Publications (2)

• deKay JT, Chepurko E, Chepurko V, Knudsen L, Lord C, Searight M, Tsibulnikov S, Robich MP, Sawyer DB, Gagnon DJ, May T, Riker R, Seder DB, Ryzhov S. Delayed CCL23 response is associated with poor outcomes after cardiac arrest. Cytokine. 2024 Apr;176:156536. doi: 10.1016/j.cyto.2024.156536. Epub 2024 Feb 6.

  PMID: 38325139 BACKGROUND

• Ryzhov S, May T, Dziodzio J, Emery IF, Lucas FL, Leclerc A, McCrum B, Lord C, Eldridge A, Robich MP, Ichinose F, Sawyer DB, Riker R, Seder DB. Number of Circulating CD 73-Expressing Lymphocytes Correlates With Survival After Cardiac Arrest. J Am Heart Assoc. 2019 Jul 2;8(13):e010874. doi: 10.1161/JAHA.118.010874. Epub 2019 Jun 25.

  PMID: 31237169 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Red blood cells and plasma

MeSH Terms

Conditions

Heart Arrest; Inflammation; Obesity; Hypoxia-Ischemia, Brain; Fibromatosis, Gingival, 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Hypoxia; Signs and Symptoms, Respiratory

Study Officials

• Sergey Ryzhov, MD, PhD

  MaineHealth Institute for Research

  PRINCIPAL INVESTIGATOR

• David B Seder, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David B Seder, MD

CONTACT

207-662-2179; david.seder@mainehealth.org

Sergey Ryzhov, PhD

CONTACT

sergey.ryzhov@mainehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Critical Care Services

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)