CardiotoxicityNCT04191265
Cardiotoxicity of Aluminum Phosphide Poisoning; Tropinin and CKmb as Early Biomarkers
An observational study of Cardiotoxicity and Aluminum Phosphid Poisoning, run by Assiut University at 1 site in Egypt.
Trial summary
Aluminum phosphide (AlP) or rice tablet is a cheap pesticide. When it comes in contact with acid (gastric acid) or moisture, it releases phosphine (PH3) gas. The heart,lungs, liver are the main targets in acute Aluminum phosphide (AlP) poisoning. Most deaths occur due to cardiovascular toxicity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiotoxicity, Aluminum Phosphid Poisoning
- What is being tested?
- serum tropinin, serum CKmb
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2019to 5 Jun 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Assiut governorate
Who may be able to join
- admitted with free ECG
Who cannot join
- concomitant ingesion of other drugs or toxins
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiotoxicity of Aluminum Phosphide Poisoning; Biochemical and Electrophysiological Studies and the Utility of Tropinin and CKmb as Early Biomarkers
Aluminum phosphide (AlP) or rice tablet is a cheap pesticide. When it comes in contact with acid (gastric acid) or moisture, it releases phosphine (PH3) gas. The heart,lungs, liver are the main targets in acute Aluminum phosphide (AlP) poisoning. Most deaths occur due to cardiovascular toxicity.
Read the detailed description
Aluminium phosphide is a potent respiratory chain enzyme inhibitor. Its most important effect is the inhibition of cytochrome c oxidase. The inhibition of cytochrome c oxidase and other enzymes leads to the generation of superoxide radicals and cellular peroxides , and subsequent cellular injury through lipid peroxidation and other oxidant mechanisms. It stimulates the production of hydrogen peroxide and reactive oxygen species, malonyldialdehyde (MAD), increases superoxide dismutase and inhibits catalase, peroxidase and glutathione . Oxidative stress is one of the main mechanisms of action of aluminium phosphide toxicity
- Conditions
- Cardiotoxicity, Aluminum Phosphid Poisoning
- Being tested
- serum tropinin, serum CKmb
- Keywords
- tropinin, CKmb, cardiotoxicity
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum tropinin, serum CKmbDiagnostic test
early detection of myocardial injury, allowing application of acute cardiac shock and cardiogenic shock
What is being measured
The primary outcome is the main question the study is designed to answer.
assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury
assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start5 Dec 2019
- Primary completion5 Jun 2020 (estimated)
- Study completion5 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohamed Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191265
- Sponsor's protocol ID
- cardiotoxicity of ALP cases
- Status last verified
- May 2020
- First submitted
- 5 Dec 2019
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity of Aluminum Phosphide Poisoning; Biochemical and Electrophysiological Studies and the Utility of Tropinin and CKmb as Early Biomarkers
- ClinicalTrials.gov ID
- NCT04191265
- Acronym / sponsor ID
- cardiotoxicity of ALP cases
- Conditions
- Cardiotoxicity, Aluminum Phosphid Poisoning
- Keywords
- tropinin, CKmb, cardiotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 5 Jun 2020 (estimated)
- Study completion
- 5 Jun 2020 (estimated)
- First posted
- 9 Dec 2019 (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.
Aluminum phosphide (AlP) or rice tablet is a cheap pesticide. When it comes in contact with acid (gastric acid) or moisture, it releases phosphine (PH3) gas. The heart,lungs, liver are the main targets in acute Aluminum phosphide (AlP) poisoning. Most deaths occur due to cardiovascular toxicity.
Detailed description
Aluminium phosphide is a potent respiratory chain enzyme inhibitor. Its most important effect is the inhibition of cytochrome c oxidase. The inhibition of cytochrome c oxidase and other enzymes leads to the generation of superoxide radicals and cellular peroxides , and subsequent cellular injury through lipid peroxidation and other oxidant mechanisms. It stimulates the production of hydrogen peroxide and reactive oxygen species, malonyldialdehyde (MAD), increases superoxide dismutase and inhibits catalase, peroxidase and glutathione . Oxidative stress is one of the main mechanisms of action of aluminium phosphide toxicity
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Assiut governorate
Key inclusion criteria (1 listed)
- admitted with free ECG
Key exclusion criteria (2 listed)
- concomitant ingesion of other drugs or toxins
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum tropinin, serum CKmbearly detection of myocardial injury, allowing application of acute cardiac shock and cardiogenic shock | Diagnostic test | – |
Primary outcome
assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury
Time frame: 6 months
assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiotoxicity and Aluminum Phosphid Poisoning, run by Assiut University at 1 site in Egypt.
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 2 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 13 May 2020. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury (time frame: 6 months). 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 13 May 2020.