Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation

Sponsor
The Third People's Hospital of Hangzhou (Other)
Overall Status
Recruiting
CT.gov ID
NCT06002750
Collaborator
(none)
280
1
9
31.2

Study Details

Study Description

Brief Summary

The goal of this observational study is to investigate ventricular repolarization utilizing Tp-e intervals and Tp-e/QT ratios in patients with DM. The main questions it aims to answer are:

  • 1.Exploring the changes in ventricular repolarization parameters (QT interval, QTc interval, QTd, Tp-e interval, Tp-e/QT ratio) in patients with dermatomyositis, providing quantifiable indicators for early detection of arrhythmia in dermatomyositis patients;

  • 2.Exploring the role of inflammation in ventricular repolarization in DM patients, providing a basis for in-depth research on the diagnosis and prevention of arrhythmia in DM patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    280 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    The Third People's Hospital of Hangzhou
    Actual Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Dermatomyositis patients

    The control group was comprised of age- and gender-matched healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients. [January 2017 to October 2022]

    2. the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation. [January 2017 to October 2022]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Regardless of gender, registered residence and education level, voluntarily participate in this study and sign the informed consent form.

    Clinical diagnosis of Dermatomyositis.

    Exclusion Criteria:

    Previous history of heart disease (such as myocardial infarction, cardiac pacing, congenital heart disease, ischemic heart disease, etc.), chronic kidney disease, etc; Patients with other connective tissue diseases; Pregnant and lactating women.

    Taking drugs that affect electrocardiogram indicators, such as macrolides, quinolones, quinidine, amiodarone, antipsychotic drugs, etc.

    Patients with severe lack of case data.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Third People's Hospital of Hangzhou Zhejiang Hangzhou China 310000

    Sponsors and Collaborators

    • The Third People's Hospital of Hangzhou

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Third People's Hospital of Hangzhou
    ClinicalTrials.gov Identifier:
    NCT06002750
    Other Study ID Numbers:
    • 2021KA048
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2023