- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04422535
Effects on the Qt Interval of COVID-19 Coronavirus Infection (QT-COVID-19)
Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients
Study Overview
Status
Conditions
Detailed Description
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.
Relevant 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Matilde Zaballos, MDPhD
- Phone Number: 0034657813987
- Email: mati@plagaro.net
Study Contact Backup
- Name: Javier Hortal, MD PhD
- Phone Number: 915868367
- Email: javier.hortal@gmail.com
Study Locations
-
-
-
Madrid, Spain, 28007
- Recruiting
- Servicio de Anestesia, Hospital General Universitario Gregorio Marañon
-
Contact:
- Matilde Zaballos, MD, PhD
- Phone Number: 0034915868367
- Email: mati@plagaro.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Patients admitted to critical care units with COVID-19 infection
- Ages between 18-80 years
- Documentation in the clinical history sufficient to collect the data of interest to the study.
Description
Inclusion Criteria:
- Patients admitted to intensive care units for COVID-19 infection with an ECG record
Exclusion Criteria:
- Patients in critical care unit without COVID-19 infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Critical care patients
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of arrhythmias and impact of the COVI-drugs administered on QT interval
Time Frame: through study completion, an average of 1 year
|
To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units. To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval. |
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Javier Hortal, MD PhD, Hospital Universitario Gregorio Marañon
Publications and helpful links
General Publications
- 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. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QT-COVID-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronavirus Infection
-
The University of Hong KongHospital Authority, Hong KongCompletedNovel Coronavirus InfectionHong Kong
-
Affiliated Hospital to Academy of Military Medical...Beijing 302 HospitalUnknownNovel Coronavirus Infection PneumoniaChina
-
ProgenaBiomeDSCS CRORecruitingCOVID-19 | Coronavirus Infection | COVID | Corona Virus Infection | Coronavirus | Sars-CoV2 | Coronavirus-19 | Coronavirus 19United States
-
AudibleHealth AI, Inc.Sunrise Research Institute; Analytical Solutions Group, Inc.; Kelley Medical... and other collaboratorsCompletedCoronavirus Disease 2019 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19 | COVID-19 Virus Disease | 2019 Novel Coronavirus Disease | 2019 Novel Coronavirus Infection | 2019-nCoV DiseaseUnited States
-
Concern GRANITSamara State Medical UniversityCompletedCoronavirus Infection COVID-19Russian Federation
-
D'Or Institute for Research and EducationUnknown
-
Chelsea and Westminster NHS Foundation TrustUnknownCOVID-19 | COVID-19 Infection | 2019 Novel Coronavirus InfectionUnited Kingdom
-
Institut National de la Santé Et de la Recherche...Recruiting
-
Kansas City Heart Rhythm InstituteTerminated
-
Universidade Federal de Sao CarlosTerminatedCoronavirus InfectionBrazil