- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490317
CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
May 1, 2023 updated by: Yong Sung Cha, Wonju Severance Christian Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
1500
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
- Name: Yong Sung Cha, MD
- Phone Number: +82-33-741-1615
- Email: emyscha@yonsei.ac.kr
Study Locations
-
-
Gangwon
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Wonju, Gangwon, Korea, Republic of, 26426
- Recruiting
- Wonju Severance Christian Hospital
-
Contact:
- Yong Sung Cha, MD
- Phone Number: +82-33-741-1615
- Email: emyscha@yonsei.ac.kr
-
Principal Investigator:
- Yong Sung Cha, MD
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Acute CO poisoning
Description
Inclusion Criteria:
- Acute CO poisoning
Exclusion Criteria:
- Declined to enrollment in the study
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute CO poisoning
A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin >5% (>10% in smokers).
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic response to HBO at 1 month
Time Frame: At 1 month after CO exposure
|
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
|
Therapeutic response to HBO at 6 months
Time Frame: At 6 months after CO exposure
|
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
|
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
Time Frame: Within 1 month after CO exposure
|
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
|
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
Time Frame: Within 1 month after CO exposure
|
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
|
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
Time Frame: Within 1 month after CO exposure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic response to HBO at 12 months
Time Frame: At 12 months after CO exposure
|
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
|
Therapeutic response to TH combined with HBO at 1 month
Time Frame: At 1 month after CO exposure
|
Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure
|
At 1 month after CO exposure
|
Therapeutic response to TH combined with HBO at 6 months
Time Frame: At 6 months after CO exposure
|
Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure
|
At 6 months after CO exposure
|
Therapeutic response to TH combined with HBO at 12 months
Time Frame: At 12 months after CO exposure
|
Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure
|
At 12 months after CO exposure
|
Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month
Time Frame: At 1 month after CO exposure
|
Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure
|
At 1 month after CO exposure
|
Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months
Time Frame: At 6 months after CO exposure
|
Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure
|
At 6 months after CO exposure
|
Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure
Time Frame: 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
|
Cardiac injury evaluated by cardiac MRI in acute phase
Time Frame: Within 1 month after CO exposure
|
Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase
|
Within 1 month after CO exposure
|
Cardiac injury evaluated by cardiac MRI in chronic phase
Time Frame: Follow-up cardiac MRI (at 4-8 months after CO exposure)
|
Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase
|
Follow-up cardiac MRI (at 4-8 months after CO exposure)
|
Cardiac injury evaluated by cardiac CT
Time Frame: Within 1 month after CO exposure
|
Cardiac injury evaluated by cardiac CT in CO poisoning
|
Within 1 month after CO exposure
|
Cardiac injury evaluated by TTE in acute phase
Time Frame: Within 14 days after CO exposure
|
Cardiac injury related to CO poisoning evaluated by TTE in acute phase
|
Within 14 days after CO exposure
|
Cardiac injury evaluated by TTE in chronic phase
Time Frame: Within 4-8 months after CO exposure
|
Cardiac injury related to CO poisoning evaluated by TTE in chronic phase
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Within 4-8 months after CO exposure
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Brain injury evaluated by brain imaging modality related to CO poisoning
Time Frame: Within 6 months after CO exposure
|
Brain injury evaluated by brain MRI in CO poisoning
|
Within 6 months after CO exposure
|
Brain injury related to CO poisoning
Time Frame: Within 6 months after CO exposure
|
Brain injury evaluated by laboratory tests in CO poisoning
|
Within 6 months after CO exposure
|
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
Time Frame: Outcomes 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
|
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
Time Frame: Outcomes 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
|
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
Time Frame: Outcomes 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
|
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
Time Frame: Outcomes 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
|
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
Time Frame: Outcomes at 1 month after CO exposure
|
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
|
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
Time Frame: Outcomes at 6 months after CO exposure
|
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
|
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
Time Frame: Outcomes at 12 months after CO exposure
|
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
|
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
Time Frame: Outcomes at 5 years after CO exposure
|
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
|
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
Time Frame: Outcomes at 1 month after CO exposure
|
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
|
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
Time Frame: Outcomes at 6 months after CO exposure
|
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
|
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
Time Frame: Outcomes at 12 months after CO exposure
|
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
|
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
Time Frame: Outcomes at 5 years after CO exposure
|
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
|
Therapeutic response to drugs at 1 month
Time Frame: At 1 month after CO exposure
|
Therapeutic response to additional drug including steroid at 1 month after CO exposure
|
At 1 month after CO exposure
|
Therapeutic response to drugs at 6 months
Time Frame: At 6 months after CO exposure
|
Therapeutic response to additional drug including steroid at 6 months after CO exposure
|
At 6 months after CO exposure
|
Therapeutic response to drugs at 12 months
Time Frame: At 12 months after CO exposure
|
Therapeutic response to additional drug including steroid at 12 months after CO exposure
|
At 12 months after CO exposure
|
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month
Time Frame: At 1 month after CO exposure
|
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
|
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months
Time Frame: At 6 months after CO exposure
|
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
|
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months
Time Frame: At 12 months after CO exposure
|
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
|
Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years
Time Frame: At 5 years after CO exposure
|
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
|
Organ injury related to CO poisoning
Time Frame: Within 6 months after CO exposure
|
Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning
|
Within 6 months after CO exposure
|
Complications related to CO poisoning
Time Frame: Within 6 months after CO exposure
|
Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning
|
Within 6 months after CO exposure
|
Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset
Time Frame: Within 1 year after delayed neurocognitive and psychological sequelae 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
|
Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset
Time Frame: Within 2 years after delayed neurocognitive and psychological sequelae 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
|
Validation of methods evaluating neurocognitive and psychological outcomes
Time Frame: Within 6 months after CO exposure
|
Validation of methods evaluating neurocognitive and psychological outcomes within 6 months
|
Within 6 months after CO exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yong Sung Cha, MD, Wonju Severance Christian Hospital
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)
July 29, 2020
Primary Completion (Anticipated)
December 1, 2030
Study Completion (Anticipated)
December 1, 2035
Study Registration Dates
First Submitted
July 21, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (Actual)
July 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARE CO cohort
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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