Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection

Cardiotoxicity Clinical Trial

Official title:

Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060132
• Other study ID #: YSS001
• Status: Recruiting
• Start date: January 29, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Qianfoshan Hospital
• Contact: Yi Han, doctorate
• Phone: 15552565120
• Email: 15552565120[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with incomplete clinical information

Related Conditions & MeSH terms

• Adverse Reaction
• Cardiotoxicity

Intervention

Drug:
• Sodium arsenite chloride injection
Patient use of arsenite sodium chloride injection

Locations

Country	Name	City	State
China	China	Jinan	Shandong
China	First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arrhythmia	Electrocardiogram shows arrhythmia with marked QT prolongation	through study completion, an average of 1 year
Primary	adverse reaction	All cardiac-related adverse events in the course of the disease regimen	through study completion, an average of 1 year
Primary	troponin	Troponin values	through study completion, an average of 1 year
Primary	Echocardiogram LVEF	Echocardiogram LVEF values	through study completion, an average of 1 year