Baseline Investigation of Patients With Cardiac Arrest in China

Cardiac Arrest Clinical Trial

— BASIC  

Official title:

Baseline Investigation of Patients With Cardiac Arrest in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926325
• Other study ID #: QLEmer201904
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Qilu Hospital of Shandong University
• Contact: Feng Xu, Dr
• Phone: +86-18560083066
• Email: xufengsdu[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (73)

Lead Sponsor

Collaborator

Qilu Hospital of Shandong University

Beijing Chao Yang Hospital, Beijing Children's Hospital Affiliated to the Capital Medical University, Beijing Emergency Medical Center, Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing Red Cross Emergency Rescue Center, Chang shu No.1 People's Hospital, Changchun Emergency Medical Center, China-Japan Friendship Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Chongqing Emergency Medical Center, Emergency Center of Yunan Province, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, First Hospital of Qinhuangdao, Fudan University, Guangzhou Emergency Medical Command Center, Haikou Emergency Medical Center, Hainan Medical College, Hangzhou Emergency Medical Center, Hefei Emergency Medical Center, Heilongjiang Emergency Medical Center, Henan Provincial People's Hospital, Hohhot 120 Emergency Medical Center, Hunan Provincial People's Hospital, Jinan Emergency Medical Center, Lanzhou university second hospital, Nanning Emergency Medical Center, National Center for Cardiovascular Disease, 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, Nong'an County People's Hospital, Nyingchi People's Hospital, Peking University Third Hospital, People's Hospital of Ningxia Hui Autonomous Region, People's Hospital of Wanning, Qianjiang Central Hospital, Qinghai People's Hospital, Qinhuangdao Emergency Dispatching Center, RenJi Hospital, Renmin Hospital of Wuhan University, Santai County People's Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Changzheng Hospital, Shanghai Emergency Medical Center, Shenyang Emergency Center, Siziwang Banner People's Hospital of Inner Mongolia, Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Taiyuan Emergency Medical Center, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital of Inner Mongolia Medical University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang Medical University, The First Affiliated Hospital of Shanxi Medical University, The First Hospital of Jilin University, The General Hospital of TianJin Medical University, Tianjin Emergency Medical Center, Tiantan Hospital, Capital Medical University, Wenshang County People's Hospital, West China Hospital, Wuhan Emergency Medical Center, Wushan County People's Hospital, Xi'an Emergency Medical Center, Xiangya Hospital of Central South University, Xuzhou Ambulance Center, Yinchuan Emergency Medical Center, Zhenzhou Emergency Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of OHCA treated by EMS		Latest data inclusion June 30, 2022
Primary	incidence of IHCA		Latest data inclusion June 30, 2022
Primary	survival to hospital discharge or 30d survival of OHCA		at hospital discharge, 30days after cardiac arrest occurs
Primary	survival to hospital discharge or 30d survival of IHCA		at hospital discharge, 30days after cardiac arrest occurs
Primary	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	at hospital discharge, 30days after cardiac arrest occurs
Secondary	survival of OHCA		6 months and 1 year after cardiac arrest occurs
Secondary	survival of IHCA		6 months and 1 year after cardiac arrest occurs
Secondary	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	6 months and 1 year after cardiac arrest occurs
Secondary	rate of return of spontaneous circulation		Latest data inclusion June 30,2022