NCT02297776

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

November 16, 2014

Last Update Submit

November 21, 2014

Conditions

Keywords

cardiac arrestbiomarkermicroRNAcircRNANSECPC

Outcome Measures

Primary Outcomes (1)

  • cerebral performance Category(CPC) of Participants

    up to 6 months after cardiopulmonary resuscitation

Secondary Outcomes (2)

  • survival of participants

    up to 28 days after hospitalization

  • cerebral performance Category(CPC) of Participants

    up to 2 weeks after cardiopulmonary resuscitation

Study Arms (2)

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

Eligibility Criteria

Age14 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth Hospital

Shanghai, 200000, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples are to be retained.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yuanzhuo Chen, MD

    Shanghai 10th People's Hospital

    STUDY CHAIR
  • Wenjie Li, MD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR
  • Huiqi Wang, MD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR
  • Chengjin Gao, MD

    Shanghai 10th People's Hospital

    STUDY DIRECTOR
  • Hu Peng, MD

    Shanghai 10th People's Hospital

    STUDY DIRECTOR
  • Yugang Zhuang, MD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR
  • Xiangyu Zhang, MD

    Shanghai 10th People's Hospital

    STUDY DIRECTOR
  • Qixing Wang

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Li, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 16, 2014

First Posted

November 21, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations