- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926325
Baseline Investigation of Patients With Cardiac Arrest in China (BASIC)
October 2, 2022 updated by: Feng Xu, Qilu Hospital of Shandong University
BASIC is a perspective, multicentre and large-scale registry focusing on of patients suffering a cardiac arrest in China.
The aims of the study are to establish the monitoring sites covering out-of-hospital cardiac arrest (OHCA) and in-hospital cardiac arrest (IHCA) in urban and rural areas in 7 regions (East China, North China, South China, Central China, Northeast China, Southwest China and Northwest China) around China, to collect data from cardiac arrest patients, and to describe basic characteristics, treatments, outcomes, incidences and risk factors of OHCA and IHCA in China.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
200000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feng Xu, Dr
- Phone Number: +86-18560083066
- Email: xufengsdu@126.com
Study Contact Backup
- Name: Chang Pan, Dr
- Phone Number: +86-18560082290
- Email: panchang0517@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong University
-
Contact:
- Feng Xu, Dr
- Phone Number: +86-18560083066
- Email: xufengsdu@126.com
-
Contact:
- Chang Pan, Dr
- Phone Number: +86-18560082290
- Email: panchang0517@163.com
-
Principal Investigator:
- Feng Xu, Dr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
consecutive patients with cardiac arrest
Description
Inclusion Criteria:
- OHCA: Every patient who suffered a cardiac arrest that occurred in any location other than a hospital, and was attended and/or treated by an EMS.
- IHCA: Every patient who suffered a cardiac arrest in hospital.
- the representative population-based survey: Every patient who suffered a cardiac arrest in the selected cities or suburbs.
Exclusion Criteria:
- OHCA: 1)The out-of-hospital cardiac arrest patients who were taken to the hospital by their family members; 2) Bystanders suspected cardiac arrest, but the ROSC was achieved without defibrillation or resuscitation by EMS.
- IHCA: The patient who suffered a cardiac arrest that occurred out-of-hospital and then transferred to the hospital.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of OHCA treated by EMS
Time Frame: Latest data inclusion June 30, 2022
|
Latest data inclusion June 30, 2022
|
|
incidence of IHCA
Time Frame: Latest data inclusion June 30, 2022
|
Latest data inclusion June 30, 2022
|
|
survival to hospital discharge or 30d survival of OHCA
Time Frame: at hospital discharge, 30days after cardiac arrest occurs
|
at hospital discharge, 30days after cardiac arrest occurs
|
|
survival to hospital discharge or 30d survival of IHCA
Time Frame: at hospital discharge, 30days after cardiac arrest occurs
|
at hospital discharge, 30days after cardiac arrest occurs
|
|
prevalence of favorable neurological outcome after cardiac arrest according to Cerebral Performance Category (CPC) Scale
Time Frame: at hospital discharge, 30days after cardiac arrest occurs
|
CPC 1 and 2 as a favorable neurological outcome; CPC 1, Good Cerebral Performance; CPC 2, Moderate Cerebral Disability; CPC 3, Severe Cerebral Disability; CPC 4, Coma, vegetative state; CPC 5, Brain death
|
at hospital discharge, 30days after cardiac arrest occurs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival of OHCA
Time Frame: 6 months and 1 year after cardiac arrest occurs
|
6 months and 1 year after cardiac arrest occurs
|
|
survival of IHCA
Time Frame: 6 months and 1 year after cardiac arrest occurs
|
6 months and 1 year after cardiac arrest occurs
|
|
prevalence of favorable neurological outcome after cardiac arrest according to Cerebral Performance Category (CPC) Scale
Time Frame: 6 months and 1 year after cardiac arrest occurs
|
CPC 1 and 2 as a favorable neurological outcome; CPC 1, Good Cerebral Performance; CPC 2, Moderate Cerebral Disability; CPC 3, Severe Cerebral Disability; CPC 4, Coma, vegetative state; CPC 5, Brain death
|
6 months and 1 year after cardiac arrest occurs
|
rate of return of spontaneous circulation
Time Frame: Latest data inclusion June 30,2022
|
Latest data inclusion June 30,2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Feng Xu, Dr, Qilu Hospital of Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 19, 2019
First Submitted That Met QC Criteria
April 22, 2019
First Posted (Actual)
April 24, 2019
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 2, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLEmer201904
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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