Cardiac ArrestCABNONCT02297776
Circulating Biomarkers Predict Neurological Outcome After Cardiac Arrest
An observational study of Cardiac Arrest, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: transferred to or hospitalized in the emergency department or other wards of Shanghai Tenth People's Hospital due to cardiac arrest
1 Inclusion criteria:
- 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.
2 Exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
Wenjie Li, MD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth Hospital
Shanghai, 200000
Yuanzhuo Chen, MD, chenyuanzhuo021@hotmail.com
About this study
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
- 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.
- 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.
- 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.
- 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.
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, biomarker, microRNA, circRNA, NSE, CPC
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
cerebral performance Category(CPC) of Participants
Measured: up to 6 months after cardiopulmonary resuscitation
Secondary outcomes (2)
survival of participants
Measured: up to 28 days after hospitalization
cerebral performance Category(CPC) of Participants
Measured: up to 2 weeks after cardiopulmonary resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yuanzhuo, Shanghai 10th People's Hospital
- Investigators
- Yuanzhuo Chen, MD, Study chair, Shanghai 10th People's HospitalWenjie Li, MD, Principal investigator, Shanghai 10th People's HospitalHuiqi Wang, MD, Principal investigator, Shanghai 10th People's HospitalChengjin Gao, MD, Study director, Shanghai 10th People's HospitalHu Peng, MD, Study director, Shanghai 10th People's HospitalYugang Zhuang, MD, Principal investigator, Shanghai 10th People's HospitalXiangyu Zhang, MD, Study director, Shanghai 10th People's HospitalQixing Wang, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297776
- Sponsor's protocol ID
- 040114001
- Acronym
- CABNO
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Biomarkers Predict Neurological Outcome After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02297776
- Acronym / sponsor ID
- CABNO / 040114001
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, biomarker, microRNA, circRNA, NSE, CPC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- transferred to or hospitalized in the emergency department or other wards of Shanghai Tenth People's Hospital due to cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cerebral performance Category(CPC) of Participants
Time frame: up to 6 months after cardiopulmonary resuscitation
2 secondary outcomes
survival of participants
Time frame: up to 28 days after hospitalization
cerebral performance Category(CPC) of Participants
Time frame: up to 2 weeks after cardiopulmonary resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 32293300Zhuang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenjie Li, MD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanzhuo Chen, MD (+821666304586, chenyuanzhuo021@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral performance Category(CPC) of Participants (time frame: up to 6 months after cardiopulmonary resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.