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

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ClinicalTrials.gov Identifier: NCT03926325

Recruitment Status : Not yet recruiting

First Posted : April 24, 2019

Last Update Posted : April 30, 2019

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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

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 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

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

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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

U.S. FDA Resources

Groups and Cohorts

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

Information from the National Library of Medicine

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Layout table for eligibility information

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