Carbon Monoxide PoisoningCOCARDIOTOXNCT06549621
Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy
An observational study of Carbon Monoxide Poisoning, run by University Hospital, Brest at 1 site in France.
Trial summary
Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carbon Monoxide Poisoning
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2022to 25 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients treated for CO poisoning with HBOT following European and French recommendations in our department from 2015/01/01 to 2021/12/31
Who may be able to join
- Patients treated for CO poisoning with HBOT in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2021/12/31
Who cannot join
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury.
This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning
Read the detailed description
This is a single-center retrospective study on health data. The methodology includes a collection of data on health and history data of patients treated by HBOT fo CO poisoning between 01/01/2015 and 31/12/2021 and carrying out a telephone interview of patients who have had early cardiovascular manifestations of CO poisoning.
One month between the start of theses interviews, an information letter on the study is sent by post, giving the possibility of opposing it.
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- cardiac injury, cardiac toxicity
- Medical subject headings
- Carbon Monoxide Poisoning, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
early and late cardiac injury due to CO poisoning description
clinical manifestation, troponin elevation and/or ECG abnormality during acute CO poisoning description; then late cardiac manifestation and abnormality declared by patients who have had early cardiac abnormality (troponin elevation and/or ECG abnormalities)
Measured: enrollment (inclusion)
Secondary outcomes (5)
relationship between the source of CO poisoning and cardiac injury
comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test
Measured: enrollment (inclusion)
relationship between context of poisoning (domestic, professionnal or intentional poisoning) and cardiac injury
comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test
Measured: enrollment (inclusion)
relationship between other possibly associated poisoning and cardiac injury
comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test
Measured: enrollment (inclusion)
relationship between severity of neurological symptoms and cardiac injury
comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test
Measured: enrollment (inclusion)
relationship between cardiovascular risk factors or preexisting cardio vascular abnormality and cardiac injury
comparison between the group of patients with early cardiac abnormalities (troponin elevation and/or ECG abnormalities) and the group of patients without early cardiac abnormalities using Ficher test
Measured: enrollment (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start25 Jul 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549621
- Sponsor's protocol ID
- COCARDIOTOX (29BRC22.0049)
- Acronym
- COCARDIOTOX
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT06549621
- Acronym / sponsor ID
- COCARDIOTOX / COCARDIOTOX (29BRC22.0049)
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- cardiac injury, cardiac toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury.
This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning
Detailed description
This is a single-center retrospective study on health data. The methodology includes a collection of data on health and history data of patients treated by HBOT fo CO poisoning between 01/01/2015 and 31/12/2021 and carrying out a telephone interview of patients who have had early cardiovascular manifestations of CO poisoning.
One month between the start of theses interviews, an information letter on the study is sent by post, giving the possibility of opposing it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients treated for CO poisoning with HBOT following European and French recommendations in our department from 2015/01/01 to 2021/12/31
Key inclusion criteria (1 listed)
- Patients treated for CO poisoning with HBOT in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2021/12/31
Key exclusion criteria (1 listed)
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
early and late cardiac injury due to CO poisoning description
Time frame: enrollment (inclusion)
clinical manifestation, troponin elevation and/or ECG abnormality during acute CO poisoning description; then late cardiac manifestation and abnormality declared by patients who have had early cardiac abnormality (troponin elevation and/or ECG abnormalities)
5 secondary outcomes
relationship between the source of CO poisoning and cardiac injury
Time frame: enrollment (inclusion)
relationship between context of poisoning (domestic, professionnal or intentional poisoning) and cardiac injury
Time frame: enrollment (inclusion)
relationship between other possibly associated poisoning and cardiac injury
Time frame: enrollment (inclusion)
relationship between severity of neurological symptoms and cardiac injury
Time frame: enrollment (inclusion)
relationship between cardiovascular risk factors or preexisting cardio vascular abnormality and cardiac injury
Time frame: enrollment (inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact anne Henckes (02 98 34 70 98, anne.henckes@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early and late cardiac injury due to CO poisoning description (time frame: enrollment (inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.