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出境医 / 临床实验 / Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance (CAPTURES)

Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance (CAPTURES)

Study Description
Brief Summary:

Identification of Causes and Risk Factors for Out-of-Hospital Cardiac Arrest through Development of Prediction Model and Novel Biomarkers

Study Objectives:

  1. To identify causes and risk factors of OHCA incidence that are associated with chronic diseases and health behaviors
  2. To identify high risk population for OHCA incidence through development of a prediction model
  3. To develop novel biomarkers associated with OHCA incidence, survival, and disabilities

Condition or disease
Cardiac Arrest, Out-Of-Hospital

Detailed Description:

Study design: Multicenter case-control study, 14 tertiary teaching hospital emergency departments in Korea

Study period: September 2017 to December 2023 (75 months)

Study population: Early cardiac arrest patients aged between 19 and 79 (1,780 cases) and their age-, gender-, and urban/rural area-matched community controls (3,560 cases).

  • Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals. A prospective OHCA patient cohort will be developed and all survived OHCA cases will be followed at 1-month, 6-month, and 12-month after ED discharge by telephone. During the study period, the investigators aim to recruit a total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023).
  • matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their annual routine physical examinations. During the study period, the investigators aim to recruit a total 3,560 controls (400 controls between September 2017 and August 2018, 1200 controls between September 2018 and August 2020, 160 controls between September 2020 and December 2020, and 1800 controls between January 2021 and December 2023).

Data collection: Following data will be collected for both cases and controls.

  • Clinical data: Basic demographic and clinical outcomes will be retrieved from medical records.
  • Survey data: Comorbidity, family history of selected diseases, lifestyle behaviors (including smoking, alcohol, physical activity, sleeping, nutrition, marital status, occupation), and history of selected chronic diseases data will be collected.
  • Blood samples: The investigators aim to develop both clinical and behavioral (including nutrition, alcohol, and smoking) biomarkers of OHCA. The investigators also plan to further develop OHCA biomarkers using proteomics, genomics, and metabolomics.
  • Follow-ups: All survived OHCA cases will be followed-up at 1-month, 6-month, and 12-month after ED discharge and their survival, disability, and quality of life outcomes will be collected by telephone.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5340 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Group/Cohort
Early cardiac arrest patients
Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals. A prospective OHCA patient cohort will be developed and all survived OHCA cases will be followed at 1-month and 6-month after ED discharge by telephone. During the study period, the investigators aim to recruit a total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023).
Matched community-based controls
Matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their annual routine physical examinations. During the study period, the investigators aim to recruit a total 3,560 controls (400 controls between September 2017 and August 2018, 1200 controls between September 2018 and August 2020, 160 controls between September 2020 and December 2020, and 1800 controls between January 2021 and December 2023).
Outcome Measures
Primary Outcome Measures :
  1. Number of Participants With Out-of-hospital Cardiac Arrests [ Time Frame: A total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023) ]
    Number of participants with out-of-hospital cardiac arrests, from 19 to 79 years old.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals.
  • Matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their health screening program.
Criteria

Inclusion Criteria:

  • 19 to 79 years old
  • Out-of-hospital-cardiac arrest providing resuscitation at the site and visiting the emergency department of the participating hospital or transporting from another hospital emergency room (EMS-treated OHCA)
  • The cardiac arrest event must not have been predicted for 24 hours before the incident

Exclusion Criteria:

  • People who do not consent to personal information and blood supply for research
  • Trauma, submersion, poisoning, hanging, suffocation, or other causes of external causes directly contribute to the cardiac arrest
  • Patients with a terminal condition known to have no further treatment plans due to malignancy, neurological disease, respiratory disease, rheumatic disease, hematologic disease, renal disease or infectious disease. The terminal condition had to be checked by a doctor or recorded in medical records.
  • "Do not have a resuscitation" card or record issued by a doctor.
  • Hospice setting at the time of acute cardiac arrest for terminal illness or other reasons.
  • pregnant patient
  • With a family cannot provide information about patient
  • Without a family
  • Patients who were transported after admission at the other hospital
  • Foreign patients
Contacts and Locations

Contacts
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Contact: Jeong Ho Park 82-10-3542-6282 timthe@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang Do Shin, PhD    +82-2-2072-0854    shinsangdo@gmail.com   
Principal Investigator: Sang Do Shin, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Korean Center for Disease Control and Prevention
Tracking Information
First Submitted Date August 21, 2018
First Posted Date October 9, 2018
Last Update Posted Date May 10, 2021
Actual Study Start Date September 7, 2017
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2020)
Number of Participants With Out-of-hospital Cardiac Arrests [ Time Frame: A total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023) ]
Number of participants with out-of-hospital cardiac arrests, from 19 to 79 years old.
Original Primary Outcome Measures
 (submitted: October 8, 2018)
Number of Participants With Out-of-hospital Cardiac Arrests [ Time Frame: A total 600 cases (200 cases per year for 3 years) ]
Number of participants with out-of-hospital cardiac arrests, from 19 to 79 years old.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance
Official Title Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance
Brief Summary

Identification of Causes and Risk Factors for Out-of-Hospital Cardiac Arrest through Development of Prediction Model and Novel Biomarkers

Study Objectives:

  1. To identify causes and risk factors of OHCA incidence that are associated with chronic diseases and health behaviors
  2. To identify high risk population for OHCA incidence through development of a prediction model
  3. To develop novel biomarkers associated with OHCA incidence, survival, and disabilities
Detailed Description

Study design: Multicenter case-control study, 14 tertiary teaching hospital emergency departments in Korea

Study period: September 2017 to December 2023 (75 months)

Study population: Early cardiac arrest patients aged between 19 and 79 (1,780 cases) and their age-, gender-, and urban/rural area-matched community controls (3,560 cases).

  • Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals. A prospective OHCA patient cohort will be developed and all survived OHCA cases will be followed at 1-month, 6-month, and 12-month after ED discharge by telephone. During the study period, the investigators aim to recruit a total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023).
  • matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their annual routine physical examinations. During the study period, the investigators aim to recruit a total 3,560 controls (400 controls between September 2017 and August 2018, 1200 controls between September 2018 and August 2020, 160 controls between September 2020 and December 2020, and 1800 controls between January 2021 and December 2023).

Data collection: Following data will be collected for both cases and controls.

  • Clinical data: Basic demographic and clinical outcomes will be retrieved from medical records.
  • Survey data: Comorbidity, family history of selected diseases, lifestyle behaviors (including smoking, alcohol, physical activity, sleeping, nutrition, marital status, occupation), and history of selected chronic diseases data will be collected.
  • Blood samples: The investigators aim to develop both clinical and behavioral (including nutrition, alcohol, and smoking) biomarkers of OHCA. The investigators also plan to further develop OHCA biomarkers using proteomics, genomics, and metabolomics.
  • Follow-ups: All survived OHCA cases will be followed-up at 1-month, 6-month, and 12-month after ED discharge and their survival, disability, and quality of life outcomes will be collected by telephone.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  • Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals.
  • Matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their health screening program.
Condition Cardiac Arrest, Out-Of-Hospital
Intervention Not Provided
Study Groups/Cohorts
  • Early cardiac arrest patients
    Cases will be consecutive adult patients with EMS-treated OHCA and transport to the 14 emergency departments of participating hospitals. A prospective OHCA patient cohort will be developed and all survived OHCA cases will be followed at 1-month and 6-month after ED discharge by telephone. During the study period, the investigators aim to recruit a total 1,780 cases (200 cases between September 2017 and August 2018, 600 cases between September 2018 and August 2020, 80 cases between September 2020 and December 2020, and 900 cases between January 2021 and December 2023).
  • Matched community-based controls
    Matched community-based controls (2:1 matching) will be selected from two health screening centers. Controls are those who visit the participating health screening centers for their annual routine physical examinations. During the study period, the investigators aim to recruit a total 3,560 controls (400 controls between September 2017 and August 2018, 1200 controls between September 2018 and August 2020, 160 controls between September 2020 and December 2020, and 1800 controls between January 2021 and December 2023).
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 Recruiting
Estimated Enrollment
 (submitted: August 6, 2020)
5340
Original Estimated Enrollment
 (submitted: October 8, 2018)
3000
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 19 to 79 years old
  • Out-of-hospital-cardiac arrest providing resuscitation at the site and visiting the emergency department of the participating hospital or transporting from another hospital emergency room (EMS-treated OHCA)
  • The cardiac arrest event must not have been predicted for 24 hours before the incident

Exclusion Criteria:

  • People who do not consent to personal information and blood supply for research
  • Trauma, submersion, poisoning, hanging, suffocation, or other causes of external causes directly contribute to the cardiac arrest
  • Patients with a terminal condition known to have no further treatment plans due to malignancy, neurological disease, respiratory disease, rheumatic disease, hematologic disease, renal disease or infectious disease. The terminal condition had to be checked by a doctor or recorded in medical records.
  • "Do not have a resuscitation" card or record issued by a doctor.
  • Hospice setting at the time of acute cardiac arrest for terminal illness or other reasons.
  • pregnant patient
  • With a family cannot provide information about patient
  • Without a family
  • Patients who were transported after admission at the other hospital
  • Foreign patients
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jeong Ho Park 82-10-3542-6282 timthe@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03700203
Other Study ID Numbers 2017NE330060
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Korean Center for Disease Control and Prevention
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date May 2021