Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03447002
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-02-24', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metanephrine and normetanephrine levels', 'timeFrame': 'about 10 months', 'description': 'metanephrine and normetanephrine levels asociated premature ventricular complex frequents'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premature', 'pvc'], 'conditions': ['Premature Ventricular Contraction']}, 'referencesModule': {'references': [{'pmid': '27657474', 'type': 'BACKGROUND', 'citation': 'Im SI, Park KM, Park SJ, Kim JS, On YK. New electrocardiographic criteria for predicting successful ablation of premature ventricular contractions from the right coronary cusp. Int J Cardiol. 2016 Dec 1;224:199-205. doi: 10.1016/j.ijcard.2016.09.029. Epub 2016 Sep 16.'}, {'pmid': '24657687', 'type': 'BACKGROUND', 'citation': 'Bradfield JS, Homsi M, Shivkumar K, Miller JM. Coupling interval variability differentiates ventricular ectopic complexes arising in the aortic sinus of valsalva and great cardiac vein from other sources: mechanistic and arrhythmic risk implications. J Am Coll Cardiol. 2014 May 27;63(20):2151-2158. doi: 10.1016/j.jacc.2014.02.551. Epub 2014 Mar 19.'}, {'pmid': '38035655', 'type': 'DERIVED', 'citation': 'Cesur B, Elcik D, Cetinkaya Z, Kelesoglu S, Karabiyik U, Inanc MT, Kalay N, Ergin A, Topsakal R. Association between excess catecholamine synthesis and polymorphic premature ventricular contraction. J Electrocardiol. 2024 Jan-Feb;82:59-63. doi: 10.1016/j.jelectrocard.2023.11.010. Epub 2023 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.', 'detailedDescription': 'Premature ventricular complex is a very frequent arrhythmia. Suggested mechanisms for PVCs are reentry, triggered activity, and enhanced automaticity. Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Half-lives of catecholamines are very short and rather changeable. Therefore, 24 hours urine levels of catecholamines are the more sensitive than plasma levels. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with % 5 or higher frequents premature ventricular complex in 24 hours rhythm recording will be taken our study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* PVC's rate is more than % 5 in 24 hours rhythm recording\n\nExclusion Criteria:\n\n* ischemic heart disease\n* hyperthyroidism\n* patients with low ejection fraction"}, 'identificationModule': {'nctId': 'NCT03447002', 'briefTitle': 'Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex', 'orgStudyIdInfo': {'id': 'ErciyesU'}}, 'armsInterventionsModule': {'interventions': [{'name': '24 hours urine levels metanephrine and normetanephrine', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['rhythm recording'], 'description': '24 hours rhythm recording and 24 hours urine measurement'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes university Yilmaz- mehmet öztaşkın heart hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'burak cesur', 'investigatorFullName': 'Burak Cesur', 'investigatorAffiliation': 'TC Erciyes University'}}}}