免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Baseline Investigation of Patients With Cardiac Arrest in China (BASIC)
Baseline Investigation of Patients With Cardiac Arrest in China (BASIC)
Study Description
Brief 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, 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.
| Condition or disease |
|---|
| Cardiac Arrest |
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 100000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Baseline Investigation of Patients With Cardiac Arrest in China |
| Estimated Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 ]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
- rate of return of spontaneous circulation [ Time Frame: Latest data inclusion June 30,2022 ]
Biospecimen Retention: Samples With DNA
blood samples of cardiac arrest patients in certain centers
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
consecutive patients with cardiac arrest
Criteria
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.
Contacts and Locations
Contacts
| Contact: Feng Xu, Dr | +86-18560083066 | xufengsdu@126.com | |
| Contact: Chang Pan, Dr | +86-18560082290 | panchang0517@163.com |
Locations
| China, Shandong | |
| Qilu Hospital of Shandong University | |
| Jinan, Shandong, China, 250012 | |
| Contact: Feng Xu, Dr +86-18560083066 xufengsdu@126.com | |
| Contact: Chang Pan, Dr +86-18560082290 panchang0517@163.com | |
| Principal Investigator: Feng Xu, Dr | |
Sponsors and Collaborators
Qilu Hospital of Shandong University
Hainan Medical College
Jinan Emergency Medical Center
Wenshang County People's Hospital
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Ambulance Center
The First People's Hospital of Changzhou
The First Affiliated Hospital of Anhui Medical University
Hefei Emergency Medical Center
Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Medical 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 Affiliated to the Capital Medical University
Beijing Emergency Medical Center
Beijing Red Cross Emergency Rescue Center
The General Hospital of TianJin Medical University
Tianjin Emergency Medical Center
The Affiliated Hospital of Inner Mongolia Medical University
120 Emergency Command Center of Hohhot
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,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
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
Investigators
| Principal Investigator: | Feng Xu, Dr | Qilu Hospital of Shandong University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 19, 2019 | ||||||||
| First Posted Date | April 24, 2019 | ||||||||
| Last Update Posted Date | April 30, 2019 | ||||||||
| Estimated Study Start Date | May 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures |
|
||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Baseline Investigation of Patients With Cardiac Arrest in China | ||||||||
| Official Title | Baseline Investigation of Patients With Cardiac Arrest in China | ||||||||
| Brief 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, 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 1 Year | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
blood samples of cardiac arrest patients in certain centers
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | consecutive patients with cardiac arrest | ||||||||
| Condition | Cardiac Arrest | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
100000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2022 | ||||||||
| Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03926325 | ||||||||
| Other Study ID Numbers | QLEmer201904 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Feng Xu, Qilu Hospital of Shandong University | ||||||||
| Study Sponsor | Qilu Hospital of Shandong University | ||||||||
| Collaborators |
|
||||||||
| Investigators |
|
||||||||
| PRS Account | Qilu Hospital of Shandong University | ||||||||
| Verification Date | April 2019 | ||||||||
