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NCT06002750 Clinical Trial

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

Inflammation Clinical Trial

Official title:
The Third People's Hospital of Hangzhou

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06002750
Other study ID # 2021KA048
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date November 24, 2022

Study information
Verified date September 2023
Source The Third People's Hospital of Hangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 24, 2022
Est. primary completion date November 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• disease
Do you have dermatomyositis

Locations
Country Name City State
China The Third People's Hospital of Hangzhou Zhejiang Hangzhou

Sponsors (1)
Lead Sponsor Collaborator
The Third People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (10)

Antzelevitch C, Sicouri S, Di Diego JM, Burashnikov A, Viskin S, Shimizu W, Yan GX, Kowey P, Zhang L. Does Tpeak-Tend provide an index of transmural dispersion of repolarization? Heart Rhythm. 2007 Aug;4(8):1114-6; author reply 1116-9. doi: 10.1016/j.hrthm.2007.05.028. Epub 2007 Jun 8. No abstract available. — View Citation

Indraratna P, Tardo D, Delves M, Szirt R, Ng B. Measurement and Management of QT Interval Prolongation for General Physicians. J Gen Intern Med. 2020 Mar;35(3):865-873. doi: 10.1007/s11606-019-05477-7. Epub 2019 Oct 25. — View Citation

Kors JA, Ritsema van Eck HJ, van Herpen G. The meaning of the Tp-Te interval and its diagnostic value. J Electrocardiol. 2008 Nov-Dec;41(6):575-80. doi: 10.1016/j.jelectrocard.2008.07.030. — View Citation

Korsholm SS, Andersson DC, Knudsen JB, Dastmalchi M, Diederichsen ACP, Gerke O, Witting N, Jacobsen S, Pecini R, Friis T, Krogager ME, Lundberg IE, Diederichsen LP. Myositis-specific autoantibodies and QTc changes by ECG in idiopathic inflammatory myopathies. Rheumatology (Oxford). 2022 Oct 6;61(10):4076-4086. doi: 10.1093/rheumatology/keac013. — View Citation

Lazzerini PE, Capecchi PL, El-Sherif N, Laghi-Pasini F, Boutjdir M. Emerging Arrhythmic Risk of Autoimmune and Inflammatory Cardiac Channelopathies. J Am Heart Assoc. 2018 Nov 20;7(22):e010595. doi: 10.1161/JAHA.118.010595. No abstract available. — View Citation

Lundberg IE. Expert Perspective: Management of Refractory Inflammatory Myopathy. Arthritis Rheumatol. 2021 Aug;73(8):1394-1407. doi: 10.1002/art.41762. Epub 2021 Jun 29. — View Citation

Mendez Hernandez R, Ramasco Rueda F. Biomarkers as Prognostic Predictors and Therapeutic Guide in Critically Ill Patients: Clinical Evidence. J Pers Med. 2023 Feb 15;13(2):333. doi: 10.3390/jpm13020333. — View Citation

Naaraayan A, Meredith A, Nimkar A, Arora G, Bharati R, Acharya P. Arrhythmia prevalence among patients with polymyositis-dermatomyositis in the United States: An observational study. Heart Rhythm. 2021 Sep;18(9):1516-1523. doi: 10.1016/j.hrthm.2021.05.029. Epub 2021 May 26. — View Citation

Schwartz T, Diederichsen LP, Lundberg IE, Sjaastad I, Sanner H. Cardiac involvement in adult and juvenile idiopathic inflammatory myopathies. RMD Open. 2016 Sep 27;2(2):e000291. doi: 10.1136/rmdopen-2016-000291. eCollection 2016. — View Citation

Zhao L, Wang Q, Zhou B, Zhang L, Zhu H. The Role of Immune Cells in the Pathogenesis of Idiopathic Inflammatory Myopathies. Aging Dis. 2021 Feb 1;12(1):247-260. doi: 10.14336/AD.2020.0410. eCollection 2021 Feb. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients. November 2011 to November 2022
Primary the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation. November 2011 to November 2022
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