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Baseline Investigation of Patients With Cardiac Arrest in China (BASIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926325
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Hainan Medical College
Jinan Emergency Medical Center
Wenshang County People's Hospital
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Ambulance Center
Changshu NO.1 People's Hospital
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
Fuwai Hospital Chinese Academy of Medical Sciences
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
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 Provincial 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
National Health Commission of the People's Republic of China, Statistical information center
Xiangya Hospital of Central South University
West China Hospital
Information provided by (Responsible Party):
Feng Xu, Qilu Hospital of Shandong University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest




Primary Outcome Measures :
  1. incidence of OHCA treated by EMS [ Time Frame: Latest data inclusion June 30, 2022 ]
  2. incidence of IHCA [ Time Frame: Latest data inclusion June 30, 2022 ]
  3. survival to hospital discharge or 30d survival of OHCA [ Time Frame: at hospital discharge, 30days after cardiac arrest occurs ]
  4. survival to hospital discharge or 30d survival of IHCA [ Time Frame: at hospital discharge, 30days after cardiac arrest occurs ]
  5. 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 :
  1. survival of OHCA [ Time Frame: 6 months and 1 year after cardiac arrest occurs ]
  2. survival of IHCA [ Time Frame: 6 months and 1 year after cardiac arrest occurs ]
  3. 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

  4. 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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. 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.
  2. IHCA: Every patient who suffered a cardiac arrest in hospital.
  3. the representative population-based survey: Every patient who suffered a cardiac arrest in the selected cities or suburbs.

Exclusion Criteria:

  1. 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.
  2. IHCA: The patient who suffered a cardiac arrest that occurred out-of-hospital and then transferred to the hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926325


Contacts
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Contact: Feng Xu, Dr +86-18560083066 xufengsdu@126.com
Contact: Chang Pan, Dr +86-18560082290 panchang0517@163.com

Locations
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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
Changshu NO.1 People's Hospital
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
Fuwai Hospital Chinese Academy of Medical Sciences
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
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 Provincial 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
National Health Commission of the People's Republic of China, Statistical information center
Xiangya Hospital of Central South University
West China Hospital
Investigators
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Principal Investigator: Feng Xu, Dr Qilu Hospital of Shandong University
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Responsible Party: Feng Xu, Director of Emergency Department, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT03926325    
Other Study ID Numbers: QLEmer201904
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases