NCT06060132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

September 18, 2023

Last Update Submit

September 23, 2023

Conditions

Adverse ReactionCardiotoxicityEvaluation Study

Keywords

arsenious acidarsenic trioxidecardiotoxicity

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Sodium arsenite chloride injectionDRUG

Patient use of arsenite sodium chloride injection

Also known as: arsenic trioxide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with incomplete clinical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China

Jinan, Shandong, 250014, China

RECRUITING

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Yi Han, doctorate

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Han, doctorate

CONTACT

1555256512015552565120@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of pharmacy

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 29, 2023

Study Start

January 29, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

CN(2)