Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT03700203
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:
NCT03700203
Study Brief:
Protocol Section:
NCT03700203