Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT06002750
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2023-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QTc, Tp-e interval, and Tp-e/QT ratio were increased in DM patients.', 'timeFrame': 'November 2011 to November 2022'}, {'measure': 'the Tp-e interval and Tp-e/QT ratio were positively correlated with Inflammation.', 'timeFrame': 'November 2011 to November 2022'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatomyositis', 'Myocardial Repolarization', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '33844450', 'type': 'BACKGROUND', '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.'}, {'pmid': '33532139', 'type': 'BACKGROUND', '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.'}, {'pmid': '27752355', 'type': 'BACKGROUND', '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.'}, {'pmid': '18954608', 'type': 'BACKGROUND', '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.'}, {'pmid': '17675094', 'type': 'BACKGROUND', 'citation': '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': '34048962', 'type': 'BACKGROUND', '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.'}, {'pmid': '31654357', 'type': 'BACKGROUND', '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.'}, {'pmid': '35048961', 'type': 'BACKGROUND', '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.'}, {'pmid': '36836567', 'type': 'BACKGROUND', '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.'}, {'pmid': '30571503', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* 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;\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRegardless of gender, registered residence and education level, voluntarily participate in this study and sign the informed consent form.\n\nClinical diagnosis of Dermatomyositis.\n\nExclusion Criteria:\n\nPrevious 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.\n\nTaking drugs that affect electrocardiogram indicators, such as macrolides, quinolones, quinidine, amiodarone, antipsychotic drugs, etc.\n\nPatients with severe lack of case data.'}, 'identificationModule': {'nctId': 'NCT06002750', 'briefTitle': 'Evaluation of Tp-e Interval and Tp-e/QT Ratio in Dermatomyositis and Analysis of Their Relationship With Inflammation', 'organization': {'class': 'OTHER', 'fullName': "The Third People's Hospital of Hangzhou"}, 'officialTitle': "The Third People's Hospital of Hangzhou", 'orgStudyIdInfo': {'id': '2021KA048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dermatomyositis patients', 'interventionNames': ['Other: disease']}, {'label': 'The control group was comprised of age- and gender-matched healthy volunteers'}], 'interventions': [{'name': 'disease', 'type': 'OTHER', 'description': 'Do you have dermatomyositis', 'armGroupLabels': ['Dermatomyositis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Zhejiang', 'state': 'Hangzhou', 'country': 'China', 'facility': "The Third People's Hospital of Hangzhou", 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Third People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Ling Pin', 'investigatorAffiliation': "The Third People's Hospital of Hangzhou"}}}}