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

October 2, 2022 updated by: Feng Xu, Qilu Hospital of Shandong University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng Xu, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients with cardiac arrest

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of OHCA treated by EMS
Time Frame: Latest data inclusion June 30, 2022
Latest data inclusion June 30, 2022
incidence of IHCA
Time Frame: Latest data inclusion June 30, 2022
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
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
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
at hospital discharge, 30days after cardiac arrest occurs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
survival of OHCA
Time Frame: 6 months and 1 year after cardiac arrest occurs
6 months and 1 year after cardiac arrest occurs
survival of IHCA
Time Frame: 6 months and 1 year after cardiac arrest occurs
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
6 months and 1 year after cardiac arrest occurs
rate of return of spontaneous circulation
Time Frame: Latest data inclusion June 30,2022
Latest data inclusion June 30,2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Anhui Medical University
Xiangya Hospital of Central South University
Fudan University
Peking University Third Hospital
RenJi Hospital
West China Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Fujian Medical University
Beijing Chao Yang Hospital
China-Japan Friendship Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Hunan Provincial People's Hospital
Renmin Hospital of Wuhan University
The Affiliated Hospital Of Guizhou Medical University
Second Affiliated Hospital of Xi'an Jiaotong University
First Hospital of China Medical University
Capital Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
Qinghai People's Hospital
The First Affiliated Hospital of Shanxi Medical University
Shanghai Changzheng Hospital
First Affiliated Hospital of Xinjiang Medical University
The Affiliated Hospital of Xuzhou Medical University
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Guangxi Medical University
Chongqing Emergency Medical Center
Hainan Medical College
Beijing Emergency Medical Center
National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC
People's Hospital of Ningxia Hui Autonomous Region
Wushan County People's Hospital
Lanzhou University Second Hospital
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Jinan Emergency Medical Center
Wenshang County People's Hospital
Xuzhou Ambulance Center
Hefei Emergency Medical Center
Hangzhou Emergency Medical Center
Shanghai Emergency Medical Center
The First Affiliated Hospital of Nanchang Medical University
Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences
Beijing Children's Hospital Affiliated to the Capital Medical University
Beijing Red Cross Emergency Rescue Center
The General Hospital of TianJin Medical University
Tianjin Emergency Medical Center
Hohhot 120 Emergency Medical Center
Siziwang Banner People's Hospital of Inner Mongolia
First Hospital of Qinhuangdao
Qinhuangdao Emergency Dispatching Center
Taiyuan Emergency Medical Center
Guangzhou Emergency Medical Command Center
Haikou Emergency Medical Center
People's Hospital of Wanning
Nanning Emergency Medical Center
Wuhan Emergency Medical Center
Qianjiang Central Hospital
Zhenzhou Emergency Medical Center
Changchun Emergency Medical Center
Nong'an County People's Hospital
Shenyang Emergency Center
Heilongjiang Emergency Medical Center
Santai County People's Hospital
Emergency Center of Yunan Province
Nyingchi People's Hospital
Yinchuan Emergency Medical Center
Xi'an Emergency Medical Center
National Center for Cardiovascular Disease
National Health Commission of the People's Republic of China, Statistical information center
Chang shu No.1 People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Feng Xu, Dr, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QLEmer201904

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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