Adverse ReactionNCT06060132
Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
An observational study of Adverse Reaction and Cardiotoxicity, run by Qianfoshan Hospital at 2 sites in China.
Trial summary
To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Reaction, Cardiotoxicity, Evaluation Study
- What is being tested?
- Sodium arsenite chloride injection
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 29 Jan 2023to 31 Dec 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.
Who may be able to join
- the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
- the patient used arsenite sodium chloride injection
Who cannot join
- Patients with incomplete clinical information
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China
Jinan, Shandong, 250014
Yi Han, doctorate, 15552565120, 15552565120@163.com
- Recruiting
First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
Jinan, Shandong, 250014
Yi Han, doctorate, 15552565120, 15552565120@163.com
About this study
To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.
Read the detailed description
Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.
- Conditions
- Adverse Reaction, Cardiotoxicity, Evaluation Study
- Being tested
- Sodium arsenite chloride injection
- Keywords
- arsenious acid, arsenic trioxide, cardiotoxicity
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium arsenite chloride injectionDrug
Also called arsenic trioxide
Patient use of arsenite sodium chloride injection
What is being measured
The primary outcome is the main question the study is designed to answer.
arrhythmia
Electrocardiogram shows arrhythmia with marked QT prolongation
Measured: through study completion, an average of 1 year
adverse reaction
All cardiac-related adverse events in the course of the disease regimen
Measured: through study completion, an average of 1 year
troponin
Troponin values
Measured: through study completion, an average of 1 year
Echocardiogram LVEF
Echocardiogram LVEF values
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start29 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Han, Qianfoshan Hospital
- Investigators
- Yi Han, doctorate, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060132
- Sponsor's protocol ID
- YSS001
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
- ClinicalTrials.gov ID
- NCT06060132
- Acronym / sponsor ID
- YSS001
- Conditions
- Adverse Reaction, Cardiotoxicity, Evaluation Study
- Keywords
- arsenious acid, arsenic trioxide, cardiotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Sep 2023 (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.
To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.
Detailed description
Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.
Key inclusion criteria (2 listed)
- the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
- the patient used arsenite sodium chloride injection
Key exclusion criteria (1 listed)
- Patients with incomplete clinical information
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 |
|---|---|---|
| Sodium arsenite chloride injectionAlso: arsenic trioxidePatient use of arsenite sodium chloride injection | Drug | – |
Primary outcome
arrhythmia
Time frame: through study completion, an average of 1 year
Electrocardiogram shows arrhythmia with marked QT prolongation
adverse reaction
Time frame: through study completion, an average of 1 year
All cardiac-related adverse events in the course of the disease regimen
troponin
Time frame: through study completion, an average of 1 year
Troponin values
Echocardiogram LVEF
Time frame: through study completion, an average of 1 year
Echocardiogram LVEF values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
Yi Han, doctorate principal investigator
Qianfoshan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reaction and Cardiotoxicity, run by Qianfoshan Hospital at 2 sites in China.
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 2 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Yi Han, doctorate (15552565120, 15552565120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arrhythmia (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 29 Sep 2023.