Effects on the Qt Interval of COVID-19 Coronavirus Infection (QT-COVID-19)
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| ClinicalTrials.gov Identifier: NCT04422535 |
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Recruitment Status : Unknown
Verified May 2020 by Matilde Zaballos, Hospital General Universitario Gregorio Marañon.
Recruitment status was: Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
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| Condition or disease |
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| Coronavirus Infection Intensive Care Patients |
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 : | Observational |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients |
| Actual Study Start Date : | May 29, 2020 |
| Estimated Primary Completion Date : | September 1, 2020 |
| Estimated Study Completion Date : | December 1, 2020 |
| Group/Cohort |
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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
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- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422535
| Contact: Matilde Zaballos, MDPhD | 0034657813987 | mati@plagaro.net | |
| Contact: Javier Hortal, MD PhD | 915868367 | javier.hortal@gmail.com |
| Spain | |
| Servicio de Anestesia, Hospital General Universitario Gregorio Marañon | Recruiting |
| Madrid, Spain, 28007 | |
| Contact: Matilde Zaballos, MD, PhD 0034915868367 mati@plagaro.net | |
| Study Chair: | Javier Hortal, MD PhD | Hospital Universitario Gregorio Marañon |
| Responsible Party: | Matilde Zaballos, specialist physician at Anesthesiology Department, Hospital General Universitario Gregorio Marañon |
| ClinicalTrials.gov Identifier: | NCT04422535 |
| Other Study ID Numbers: |
QT-COVID-19 |
| First Posted: | June 9, 2020 Key Record Dates |
| Last Update Posted: | June 9, 2020 |
| Last Verified: | May 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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QT interval, ventricular repolarization |
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Infections Communicable Diseases Coronavirus Infections Disease Attributes Pathologic Processes |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases |