Cardiac ArrestBASICNCT03926325
Baseline Investigation of Patients With Cardiac Arrest in China
An observational study of Cardiac Arrest, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrest
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Dec 2023
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients with cardiac arrest
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Feng Xu, Dr, +86-18560083066, xufengsdu@126.com
Chang Pan, Dr, +86-18560082290, panchang0517@163.com
About this study
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.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of OHCA treated by EMS
Measured: Latest data inclusion June 30, 2022
incidence of IHCA
Measured: Latest data inclusion June 30, 2022
survival to hospital discharge or 30d survival of OHCA
Measured: at hospital discharge, 30days after cardiac arrest occurs
survival to hospital discharge or 30d survival of IHCA
Measured: at hospital discharge, 30days after cardiac arrest occurs
prevalence of favorable neurological outcome after cardiac arrest according to Cerebral Performance Category (CPC) Scale
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
Measured: at hospital discharge, 30days after cardiac arrest occurs
Secondary outcomes (4)
survival of OHCA
Measured: 6 months and 1 year after cardiac arrest occurs
survival of IHCA
Measured: 6 months and 1 year after cardiac arrest occurs
prevalence of favorable neurological outcome after cardiac arrest according to Cerebral Performance Category (CPC) Scale
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
Measured: 6 months and 1 year after cardiac arrest occurs
rate of return of spontaneous circulation
Measured: Latest data inclusion June 30,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (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.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- 200,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan Medical College, Jinan Emergency Medical Center, Wenshang County People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Xuzhou Ambulance Center, The First Affiliated Hospital of Anhui Medical University, Hefei Emergency Medical Center, Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou Emergency Medical Center, RenJi Hospital, Shanghai Changzheng Hospital, Shanghai Emergency Medical Center, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences, Beijing Children's Hospital, Beijing Emergency Medical Center, Beijing Red Cross Emergency Rescue Center, Tianjin Medical University General Hospital, Tianjin Emergency Medical Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 120 Emergency Medical Center, Siziwang Banner People's Hospital of Inner Mongolia, First Hospital of Qinhuangdao, Qinhuangdao Emergency Dispatching Center, The First Affiliated Hospital of Shanxi Medical University, Taiyuan Emergency Medical Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou Emergency Medical Command Center, Haikou Emergency Medical Center, People's Hospital of Wanning, First Affiliated Hospital of Guangxi Medical University, Nanning Emergency Medical Center, Renmin Hospital of Wuhan University, Wuhan Emergency Medical Center, Qianjiang Central Hospital, Henan Provincial People's Hospital, Zhenzhou Emergency Medical Center, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Changchun Emergency Medical Center, Nong'an County People's Hospital, First Hospital of China Medical University, Shenyang Emergency Center, First Affiliated Hospital of Harbin Medical University, Heilongjiang Emergency Medical Center, Santai County People's Hospital, Chongqing Emergency Medical Center, Emergency Center of Yunan Province, The Affiliated Hospital Of Guizhou Medical University, Nyingchi People's Hospital, First Affiliated Hospital of Xinjiang Medical University, Lanzhou University Second Hospital, Wushan County People's Hospital, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan Emergency Medical Center, Qinghai People's Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an Emergency Medical Center, Fudan University, National Center for Cardiovascular Disease, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Tiantan Hospital, Capital Medical University, Peking University Third Hospital, Beijing Chao Yang Hospital, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, National Health Commission of the People's Republic of China, Statistical information center, Xiangya Hospital of Central South University, West China Hospital, Chang shu No.1 People's Hospital
- Responsible party
- Principal investigator, Feng Xu, Qilu Hospital of Shandong University
- Investigators
- Feng Xu, Dr, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926325
- Sponsor's protocol ID
- QLEmer201904
- Acronym
- BASIC
- Status last verified
- Oct 2022
- First submitted
- 19 Apr 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie X, Zheng J, Zheng W, Pan C, Ma Y, Zhu Y, Tan H, Han X, Yan S, Zhang G, Li C, Shao F, Wang C, Zhang J, Bian Y, Ma J, Cheng K, Liu R, Sang S, Zhang Y, McNally B, Ong MEH, Lv C, Chen Y, Xu F; BASIC-OHCA Coordinators and Investigators. Efforts to Improve Survival Outcomes of Out-of-Hospital Cardiac Arrest in China: BASIC-OHCA. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e008856. doi: 10.1161/CIRCOUTCOMES.121.008856. Epub 2022 Dec 12.
PubMed 36503279
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Investigation of Patients With Cardiac Arrest in China
- ClinicalTrials.gov ID
- NCT03926325
- Acronym / sponsor ID
- BASIC / QLEmer201904
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Hainan Medical College, Jinan Emergency Medical Center, Wenshang County People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Xuzhou Ambulance Center, The First Affiliated Hospital of Anhui Medical University, Hefei Emergency Medical Center, Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou Emergency Medical Center, RenJi Hospital, Shanghai Changzheng Hospital, Shanghai Emergency Medical Center, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences, Beijing Children's Hospital, Beijing Emergency Medical Center, Beijing Red Cross Emergency Rescue Center, Tianjin Medical University General Hospital, Tianjin Emergency Medical Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 120 Emergency Medical Center, Siziwang Banner People's Hospital of Inner Mongolia, First Hospital of Qinhuangdao, Qinhuangdao Emergency Dispatching Center, The First Affiliated Hospital of Shanxi Medical University, Taiyuan Emergency Medical Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou Emergency Medical Command Center, Haikou Emergency Medical Center, People's Hospital of Wanning, First Affiliated Hospital of Guangxi Medical University, Nanning Emergency Medical Center, Renmin Hospital of Wuhan University, Wuhan Emergency Medical Center, Qianjiang Central Hospital, Henan Provincial People's Hospital, Zhenzhou Emergency Medical Center, Hunan Provincial People's Hospital, The First Hospital of Jilin University, Changchun Emergency Medical Center, Nong'an County People's Hospital, First Hospital of China Medical University, Shenyang Emergency Center, First Affiliated Hospital of Harbin Medical University, Heilongjiang Emergency Medical Center, Santai County People's Hospital, Chongqing Emergency Medical Center, Emergency Center of Yunan Province, The Affiliated Hospital Of Guizhou Medical University, Nyingchi People's Hospital, First Affiliated Hospital of Xinjiang Medical University, Lanzhou University Second Hospital, Wushan County People's Hospital, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan Emergency Medical Center, Qinghai People's Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an Emergency Medical Center, Fudan University, National Center for Cardiovascular Disease, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Tiantan Hospital, Capital Medical University, Peking University Third Hospital, Beijing Chao Yang Hospital, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, National Health Commission of the People's Republic of China, Statistical information center, Xiangya Hospital of Central South University, West China Hospital, Chang shu No.1 People's Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Apr 2019 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients with cardiac arrest
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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
incidence of OHCA treated by EMS
Time frame: Latest data inclusion June 30, 2022
incidence of IHCA
Time frame: 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
survival to hospital discharge or 30d survival of IHCA
Time frame: 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
4 secondary outcomes
survival of OHCA
Time frame: 6 months and 1 year after cardiac arrest occurs
survival of IHCA
Time frame: 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
rate of return of spontaneous circulation
Time frame: Latest data inclusion June 30,2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 36503279Xie X, Zheng J, Zheng W, Pan C, Ma Y, Zhu Y, Tan H, Han X, Yan S, Zhang G, Li C, Shao F, Wang C, Zhang J, Bian Y, Ma J, Cheng K, Liu R, Sang S, Zhang Y, McNally B, Ong MEH, Lv C, Chen Y, Xu F; BASIC-OHCA Coordinators and Investigators. Efforts to Improve Survival Outcomes of Out-of-Hospital Cardiac Arrest in China: BASIC-OHCA. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e008856. doi: 10.1161/CIRCOUTCOMES.121.008856. Epub 2022 Dec 12.
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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.
Feng Xu, Dr principal investigator
Qilu Hospital of Shandong University
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 Qilu Hospital of Shandong University 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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 4 Oct 2022. 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 Feng Xu, Dr (+86-18560083066, xufengsdu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of OHCA treated by EMS (time frame: Latest data inclusion June 30, 2022). The study lists 5 primary outcomes in all. 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 NCT03926325, 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 4 Oct 2022.