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

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06060132

Collaborator

(none)

400

Enrollment

Locations

Anticipated Duration (Months)

200

Patients Per Site

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Reaction Cardiotoxicity Evaluation Study	Drug: Sodium arsenite chloride injection

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

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 29, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

arrhythmia [through study completion, an average of 1 year]
Electrocardiogram shows arrhythmia with marked QT prolongation
adverse reaction [through study completion, an average of 1 year]
All cardiac-related adverse events in the course of the disease regimen
troponin [through study completion, an average of 1 year]
Troponin values
Echocardiogram LVEF [through study completion, an average of 1 year]
Echocardiogram LVEF values

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China	Jinan	Shandong	China	250014
2	First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )	Jinan	Shandong	China	250014