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Status unknownNCT02297776CABNOUpdated Nov 24, 2014

Circulating Biomarkers Predict Neurological Outcome After Cardiac Arrest

An observational study in Cardiac Arrest, sponsored by Shanghai 10th People's Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-11-24.

Sponsored by Shanghai 10th People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
14 Years to 85 Years
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Cardiac Arrest

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Keywords

  • cardiac arrest
  • biomarker
  • microRNA
  • circRNA
  • NSE
  • CPC
03

In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's planned enrollment of 160 is below the median of 200 across 382 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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.

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. cerebral performance Category(CPC) of Participants

    Time frame: up to 6 months after cardiopulmonary resuscitation

Secondary outcomes

  1. survival of participants

    Time frame: up to 28 days after hospitalization

  2. cerebral performance Category(CPC) of Participants

    Time frame: up to 2 weeks after cardiopulmonary resuscitation

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 32293300 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02297776
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Chen Yuanzhuo (M.D., Shanghai 10th People's Hospital) — Principal investigator
First posted
Nov 21, 2014
Start date
Aug 2014
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Nov 24, 2014

Study contacts

Yuanzhuo Chen, MD
Contact
chenyuanzhuo021@hotmail.com
+821666304586
Wenjie Li, MD
Contact
kingnever@hotmail.com
Yuanzhuo Chen, MD
study chair · Shanghai 10th People's Hospital
Wenjie Li, MD
principal investigator · Shanghai 10th People's Hospital
Huiqi Wang, MD
principal investigator · Shanghai 10th People's Hospital
Chengjin Gao, MD
study director · Shanghai 10th People's Hospital
Hu Peng, MD
study director · Shanghai 10th People's Hospital
Yugang Zhuang, MD
principal investigator · Shanghai 10th People's Hospital
Xiangyu Zhang, MD
study director · Shanghai 10th People's Hospital
Qixing Wang
principal investigator · Shanghai 10th People's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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