Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 5:51 AM
Study NCT ID:
NCT04422535
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects on the Qt Interval of COVID-19 Coronavirus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.'}], 'secondaryOutcomes': [{'measure': 'incidence of arrhythmias and impact of the COVI-drugs administered on QT interval', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units.\n\nTo evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QT interval, ventricular repolarization'], 'conditions': ['Coronavirus Infection', 'Intensive Care Patients']}, 'referencesModule': {'references': [{'pmid': '29898002', 'type': 'RESULT', 'citation': 'Fernandes FM, Silva EP, Martins RR, Oliveira AG. QTc interval prolongation in critically ill patients: Prevalence, risk factors and associated medications. PLoS One. 2018 Jun 13;13(6):e0199028. doi: 10.1371/journal.pone.0199028. eCollection 2018.'}, {'pmid': '21040827', 'type': 'RESULT', 'citation': 'Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Drew BJ. How many patients need QT interval monitoring in critical care units? Preliminary report of the QT in Practice study. J Electrocardiol. 2010 Nov-Dec;43(6):572-6. doi: 10.1016/j.jelectrocard.2010.05.016.'}, {'pmid': '15203254', 'type': 'RESULT', 'citation': 'Gowda RM, Khan IA, Wilbur SL, Vasavada BC, Sacchi TJ. Torsade de pointes: the clinical considerations. Int J Cardiol. 2004 Jul;96(1):1-6. doi: 10.1016/j.ijcard.2003.04.055.'}, {'pmid': '32031570', 'type': 'RESULT', 'citation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.'}, {'pmid': '32211816', 'type': 'RESULT', 'citation': 'Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.', 'detailedDescription': 'Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.\n\nRelevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients admitted to critical care units with COVID-19 infection\n* Ages between 18-80 years\n* Documentation in the clinical history sufficient to collect the data of interest to the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to intensive care units for COVID-19 infection with an ECG record\n\nExclusion Criteria:\n\n* Patients in critical care unit without COVID-19 infection'}, 'identificationModule': {'nctId': 'NCT04422535', 'acronym': 'QT-COVID-19', 'briefTitle': 'Effects on the Qt Interval of COVID-19 Coronavirus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': 'Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'QT-COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critical care patients', 'description': 'Patients admitted to critical care units for COVID-19, where ECG records and relevant clinical information are available to assess the impact of the disease and its concomitant treatment on electrocardiographic parameters of ventricular repolarization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Matilde Zaballos, MD, PhD', 'role': 'CONTACT', 'email': 'mati@plagaro.net', 'phone': '0034915868367'}], 'facility': 'Servicio de Anestesia, Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Matilde Zaballos, MDPhD', 'role': 'CONTACT', 'email': 'mati@plagaro.net', 'phone': '0034657813987'}, {'name': 'Javier Hortal, MD PhD', 'role': 'CONTACT', 'email': 'javier.hortal@gmail.com', 'phone': '915868367'}], 'overallOfficials': [{'name': 'Javier Hortal, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Gregorio Marañon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matilde Zaballos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'specialist physician at Anesthesiology Department', 'investigatorFullName': 'Matilde Zaballos', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}