Risk Analysis of Cardiotoxic Medication Use Due to Sodium... | NCT06060132

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

NCT06060132

Sponsor

Qianfoshan Hospital

Status

Unknown status

Last Update Posted

Sep 29, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Adverse Reaction
Cardiotoxicity
Evaluation Study

Interventions

Sodium arsenite chloride injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 18, 2023

First Submission Date that Met QC Criteria

Sep 23, 2023

First Posted Date

Sep 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2023

Last Update Posted Date

Sep 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium arsenite chloride injection	Drug	Patient use of arsenite sodium chloride injection		arsenic trioxide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Han, doctorate	Contact	15552565120		15552565120@163.com

Overall Officials

Name	Affiliation	Role
Yi Han, doctorate	Qianfoshan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China	Recruiting	Jinan	Shandong	250014	China

Condition Browse Module

MeSH Terms

ID	Term
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077237	Arsenic Trioxide

Ancestor Terms

ID	Term
D001152	Arsenicals
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided