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

Recruiting

• Conditions: Evaluation Study; Adverse Reaction; Cardiotoxicity

• Registration Number: NCT06060132
• Lead Sponsor: Qianfoshan Hospital

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.

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 Timeline

• Study Start: 2023-01-29
• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-23
• Last Update Submitted: 2023-09-23
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

China; 🇨🇳 Jinan, Shandong, China

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ); 🇨🇳 Jinan, Shandong, China