DermatomyositisNCT06002750
Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation
An observational study of Dermatomyositis and Myocardial Repolarization, run by The Third People's Hospital of Hangzhou at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatomyositis, Myocardial Repolarization, Inflammation
- What is being tested?
- disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2021to 24 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Regardless of gender, registered residence and education level, voluntarily participate in this study and sign the informed consent form.
- Clinical diagnosis of Dermatomyositis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Third People's Hospital of Hangzhou
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
- Being tested
- disease
- Medical subject headings
- Dermatomyositis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diseaseOther
Do you have dermatomyositis
| Study group | Role | What they receive |
|---|---|---|
| Dermatomyositis patients | Not described Receives: Other: disease | |
| The control group was comprised of age- and gender-matched healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.
Measured: November 2011 to November 2022
the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.
Measured: November 2011 to November 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start24 Nov 2021
- Primary completion23 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Pin, The Third People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002750
- Sponsor's protocol ID
- 2021KA048
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33844450Zhao 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.
PubMed 33532139Schwartz 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.
PubMed 27752355Kors 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.
PubMed 18954608Antzelevitch 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.
PubMed 17675094Naaraayan 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.
PubMed 34048962Indraratna 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.
PubMed 31654357Korsholm 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.
PubMed 35048961Mendez 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.
PubMed 36836567Lazzerini 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.
PubMed 30571503
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Third People's Hospital of Hangzhou
- ClinicalTrials.gov ID
- NCT06002750
- Acronym / sponsor ID
- 2021KA048
- Conditions
- Dermatomyositis, Myocardial Repolarization, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Third People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermatomyositis patients | – | Other: disease |
| The control group was comprised of age- and gender-matched healthy volunteers | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Regardless of gender, registered residence and education level, voluntarily participate in this study and sign the informed consent form.
- Clinical diagnosis of Dermatomyositis.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diseaseDo you have dermatomyositis | Other | Dermatomyositis patients |
Primary outcome
QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.
Time frame: November 2011 to November 2022
the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.
Time frame: November 2011 to November 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 33844450Lundberg 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.
- Background: PubMed 33532139Zhao 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.
- Background: PubMed 27752355Schwartz 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.
- Background: PubMed 18954608Kors 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.
- Background: PubMed 17675094Antzelevitch 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.
- Background: PubMed 34048962Naaraayan 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.
- Background: PubMed 31654357Indraratna 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.
- Background: PubMed 35048961Korsholm 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.
- Background: PubMed 36836567Mendez 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.
- Background: PubMed 30571503Lazzerini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis and Myocardial Repolarization, run by The Third People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients. (time frame: November 2011 to November 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002750, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.