Circulating Biomarkers Predict Neurological Outcome After Cardiac Arrest (CABNO)

Prediction of clinical outcome after cardiac arrest is clinically important.Early prognostication after successful cardiopulmonary resuscitation is difficult, and there is a need for novel methods to estimate the extent of brain injury and predict outcome. In this study, the investigators will evaluate the plasma levels of microRNAs (miRNAs) and circRNAs after cardiac arrest and assessed their ability to prognosticate neurological outcome.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest

Detailed Description

1. Diagnostic criteria for cardiac arrest Sudden loss of consciousness, carotid or femoral artery pulse disappeared, ECG showed ventricular asystole or ventricular fibrillation or ventricular tachycardia.
2. Diagnostic criteria for ROSC Recovery of complexion, autonomous aorta pulse can be detected, blood pressure> 90/60 mmHg, the condition above maintained stable for more than half an hour, defined as ROSC, otherwise as failed.
3. Clinical treatment CPR was applied according to the AHA2010 guidelines. Patients were admitted to SICU or EICU after confirmation of ROSC, and physical cooling machines were set at 33 degrees Celsius to protect brain within 24h after ROSC. Standard treatments for life support were performed for all the included patients.
4. Methods 4.1 Clinical data Data such as patient's age, gender, contact information, previous disease information, the major reason causing cardiac arrest, initial rhythm, the total time of CPR, utilization of an automatic chest compression device, time from cardiac arrest to ROSC and time from cardiac arrest to ICU admission was collected from each patient who was included in the study. Follow-up data for APARCHE II (acute physiology and chronic health evaluation scoring system) score, survival of 24 hours after cardiac arrest, survival of 48 hours after cardiac arrest, survival of 28 days after admission, CPC score 2 weeks after cardiac arrest and CPC score 6 months after cardiac arrest were collected.

4.2 Cerebral Performance Category (CPC) CPC is a 5-category scale for measuring neurological status 2 weeks after cardiac arrest and CPC score 6 months after cardiac arrest. The 5 categories are: CPC 1, conscious and alert with good cerebral performance; CPC 2, conscious and alert with moderate cerebral performance; CPC 3, conscious with severe cerebral disability; CPC 4, comatose or in persistent vegetative state; and CPC 5, brain dead, circulation preserved.

4.3 Sample collection and processing Whole blood sample was collected into Ethylene diamine tetra-acetic acid (EDTA) -anticoagulant tube from each patient immediately at the beginning of CPR, 24h, 48h and 7 days after cardiac arrest. Samples were centrifugated and the supernatant was stored in EP tube with out RNA enzyme at -80 degree Celsius.

4.4 Detection of miRNA and circRNA Patients were divided into two groups according to the Cerebral Performance Category （CPC） after half a year, "CPC 1-2 Group" and "CPC 3-5 Group". Five samples for 48h time point in each group were randomly selected and detected miRNA and circRNA with chips.The real-time quantitative PCR were used to detect the quantity of the selected miRNAs and circRNAs for each time point. The plasma concentration of NSE for each time point was tested by laboratory department.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Shanghai Tenth Hospital
    • Contact: Yuanzhuo Chen, MD; Email: chenyuanzhuo021@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

transferred to or hospitalized in the emergency department or other wards of Shanghai Tenth People's Hospital due to cardiac arrest

Description

1 Inclusion criteria:

1. Transferred to or hospitalized in the emergency department or other wards of Shanghai Tenth People's Hospital due to cardiac arrest;
2. Return of spontaneous circulation (ROSC)after cardiopulmonary resuscitation;
3. Age > 14 years and < 85 years;
4. Written informed consent was obtained from all patients'family members before entering the study.

2 Exclusion criteria:

1. No witnesses when cardiac arrest occurs;
2. Obvious neurological dysfunction prior to cardiac arrest;
3. Intracranial infection or cerebrovascular accidents as primary disease or secondary complication within six months in the follow-up period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CPC score 1 to 2; The patients with CPC score 1 to 2 judged half a year after cardiac arrest
CPC scores 3 to 5; The patients with CPC score 3 to 5 judged half a year after cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cerebral performance Category（CPC) of Participants	up to 6 months after cardiopulmonary resuscitation

Secondary Outcome Measures

Outcome Measure	Time Frame
survival of participants	up to 28 days after hospitalization
cerebral performance Category（CPC) of Participants	up to 2 weeks after cardiopulmonary resuscitation

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Yuanzhuo Chen, MD, Shanghai 10th People's Hospital; Principal Investigator: Wenjie Li, MD, Shanghai 10th People's Hospital; Principal Investigator: Huiqi Wang, MD, Shanghai 10th People's Hospital; Study Director: Chengjin Gao, MD, Shanghai 10th People's Hospital; Study Director: Hu Peng, MD, Shanghai 10th People's Hospital; Principal Investigator: Yugang Zhuang, MD, Shanghai 10th People's Hospital; Study Director: Xiangyu Zhang, MD, Shanghai 10th People's Hospital; Principal Investigator: Qixing Wang, Shanghai 10th People's Hospital

Publications and helpful links

General Publications

• Zhuang YG, Chen YZ, Zhou SQ, Peng H, Chen YQ, Li DJ. High plasma levels of pro-inflammatory factors interleukin-17 and interleukin-23 are associated with poor outcome of cardiac-arrest patients: a single center experience. BMC Cardiovasc Disord. 2020 Apr 15;20(1):170. doi: 10.1186/s12872-020-01451-y.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: November 16, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: biomarker; microRNA; cardiac arrest; NSE; circRNA; CPC
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 040114001