CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

Myocardial Injury Clinical Trial

Official title:

CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490317
• Other study ID #: CARE CO cohort
• Status: Recruiting
• Start date: July 29, 2020
• Est. completion date: December 2035

Study information

• Verified date: May 2023
• Source: Wonju Severance Christian Hospital
• Contact: Yong Sung Cha, MD
• Phone: +82-33-741-1615
• Email: emyscha[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments and short and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through various ways and the association between complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

Description:

This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments, including hyperbaric oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through a variety of ways, such as magnetic resonance image (MRI), computed tomography (CT), ultrasound, and laboratory test, and the association between various complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2035
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute CO poisoning

Exclusion Criteria:

• Declined to enrollment in the study

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Complications
• Image, Body
• Myocardial Injury
• Neurologic Deficits
• Neurologic Manifestations
• Poisoning
• Prognostic Factors
• Therapy

Intervention

Diagnostic Test:
• Cardiac MRI
Cardiac MRI be taken to CO poisoned patients Cardiac CT be taken to CO poisoned patients TTE be taken to CO poisoned patients Brain MRI be taken to CO poisoned patients Neurocognitive function tests be taken to CO poisoned patients Laboratory tests be taken to CO poisoned patients

Procedure:
• Hyperbaric oxygen therapy
Hyperbaric oxygen therapy be used for CO poisoned patients Therapeutic hypothermia be used for CO poisoned patients

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic response to HBO at 1 month	Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure	At 1 month after CO exposure
Primary	Therapeutic response to HBO at 6 months	Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure	At 6 months after CO exposure
Primary	Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests	Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month	Within 1 month after CO exposure
Primary	Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as neurocognitive function tests	Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month	Within 1 month after CO exposure
Primary	Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as neurocognitive function tests	Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month	Within 1 month after CO exposure
Secondary	Therapeutic response to HBO at 12 months	Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure	At 12 months after CO exposure
Secondary	Therapeutic response to TH combined with HBO at 1 month	Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure	At 1 month after CO exposure
Secondary	Therapeutic response to TH combined with HBO at 6 months	Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure	At 6 months after CO exposure
Secondary	Therapeutic response to TH combined with HBO at 12 months	Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure	At 12 months after CO exposure
Secondary	Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month	Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure	At 1 month after CO exposure
Secondary	Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months	Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure	At 6 months after CO exposure
Secondary	Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure	Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure	At 12 months after CO exposure
Secondary	Cardiac injury evaluated by cardiac MRI in acute phase	Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase	Within 1 month after CO exposure
Secondary	Cardiac injury evaluated by cardiac MRI in chronic phase	Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase	Follow-up cardiac MRI (at 4-8 months after CO exposure)
Secondary	Cardiac injury evaluated by cardiac CT	Cardiac injury evaluated by cardiac CT in CO poisoning	Within 1 month after CO exposure
Secondary	Cardiac injury evaluated by TTE in acute phase	Cardiac injury related to CO poisoning evaluated by TTE in acute phase	Within 14 days after CO exposure
Secondary	Cardiac injury evaluated by TTE in chronic phase	Cardiac injury related to CO poisoning evaluated by TTE in chronic phase	Within 4-8 months after CO exposure
Secondary	Brain injury evaluated by brain imaging modality related to CO poisoning	Brain injury evaluated by brain MRI in CO poisoning	Within 6 months after CO exposure
Secondary	Brain injury related to CO poisoning	Brain injury evaluated by laboratory tests in CO poisoning	Within 6 months after CO exposure
Secondary	Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure	Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure	Outcomes at 1 month after CO exposure
Secondary	Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure	Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure	Outcomes at 6 months after CO exposure
Secondary	Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure	Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure	Outcomes at 12 months after CO exposure
Secondary	Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure	Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure	Outcomes at 5 years after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 1 month after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 6 months after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 12 months after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 5 years after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 1 month after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 6 months after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 12 months after CO exposure
Secondary	Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests	Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc	Outcomes at 5 years after CO exposure
Secondary	Therapeutic response to drugs at 1 month	Therapeutic response to additional drug including steroid at 1 month after CO exposure	At 1 month after CO exposure
Secondary	Therapeutic response to drugs at 6 months	Therapeutic response to additional drug including steroid at 6 months after CO exposure	At 6 months after CO exposure
Secondary	Therapeutic response to drugs at 12 months	Therapeutic response to additional drug including steroid at 12 months after CO exposure	At 12 months after CO exposure
Secondary	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 1 month after CO exposure	At 1 month after CO exposure
Secondary	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 6 months after CO exposure	At 6 months after CO exposure
Secondary	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 12 months after CO exposure	At 12 months after CO exposure
Secondary	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years	Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 5 years after CO exposure	At 5 years after CO exposure
Secondary	Organ injury related to CO poisoning	Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning	Within 6 months after CO exposure
Secondary	Complications related to CO poisoning	Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning	Within 6 months after CO exposure
Secondary	Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset	Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset	Within 1 year after delayed neurocognitive and psychological sequelae onset
Secondary	Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset	Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset	Within 2 years after delayed neurocognitive and psychological sequelae onset
Secondary	Validation of methods evaluating neurocognitive and psychological outcomes	Validation of methods evaluating neurocognitive and psychological outcomes within 6 months	Within 6 months after CO exposure