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

NCT06002750 | Completed

• 1 other identifier: 2021KA048
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatomyositis; Myocardial Repolarization; Inflammation

Outcome Measures

Primary Outcomes (2)

• QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.

  November 2011 to November 2022

• the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.

  November 2011 to November 2022

Study Arms (2)

Dermatomyositis patients

Other: disease

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

Interventions

disease OTHER

Do you have dermatomyositis

Dermatomyositis patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dermatomyositis patients from November 2011 to November 2022 who visited our hospital, and a healthy control group consisting of the same number of gender and age matched healthy adults in a physical examination center.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third People's Hospital of Hangzhou: lead

Study Sites (1)

The Third People's Hospital of Hangzhou

Zhejiang, Hangzhou, 310000, China

Location

Related Publications (10)

• 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.

  PMID: 33844450 BACKGROUND

• 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.

  PMID: 33532139 BACKGROUND

• 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.

  PMID: 27752355 BACKGROUND

• 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.

  PMID: 18954608 BACKGROUND

• 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.

  PMID: 17675094 BACKGROUND

• 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.

  PMID: 34048962 BACKGROUND

• 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.

  PMID: 31654357 BACKGROUND

• 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.

  PMID: 35048961 BACKGROUND

• 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.

  PMID: 36836567 BACKGROUND

• 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.

  PMID: 30571503 BACKGROUND

MeSH Terms

Conditions

Dermatomyositis; Inflammation

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 21, 2023
• Study Start: November 24, 2021
• Primary Completion: November 23, 2022
• Study Completion: November 24, 2022
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)