Identification of Causes and Risk Factors for Out-of-Hospital Cardiac Arrest through Development of Prediction Model and Novel Biomarkers
Study Objectives:
Condition or disease |
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Cardiac Arrest, Out-Of-Hospital |
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).
Data collection: Following data will be collected for both cases and controls.
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 |
Group/Cohort |
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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).
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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).
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeong Ho Park | 82-10-3542-6282 | timthe@gmail.com |
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 |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures |
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.
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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:
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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).
Data collection: Following data will be collected for both cases and controls.
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | 12 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population |
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Condition | Cardiac Arrest, Out-Of-Hospital | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
5340 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years to 79 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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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 |
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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 |