An observational study in Covid19, sponsored by Ankara Education and Research Hospital. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Ankara Education and Research Hospital · Observational
Among 429 studies in COVID-19 with a site in Turkey — 9 open to participants now, 11 under way, 3 of them phase 3. COVID-19 · Turkey.
Among the 429 studies in COVID-19 with a site in Turkey, this one is the 110th largest by enrollment of the 251 observational ones, is one of 167 that started in 2020, is one of 251 observational ones, and was the 123rd registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 160 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →9 of the 429 studies in COVID-19 with a site in Turkey are open now, in 12 countries. Each count lists the studies.
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →429 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 167 started in 2020.
Median enrollment 64 across the 178 interventional studies, 148 across the 251 observational. Of the 342 that completed or were terminated, 19 (6%) have results posted.
34 of 429 have an industry lead sponsor. The 10 most frequent:
Ankara Education and Research Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.
Ankara Education and Research Hospital has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
3 of the studies in COVID-19 with a site in Turkey that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
Among the 429 studies in COVID-19 with a site in Turkey, from their registry updates:
In patients with coronavirus disease (COVID-19), severe dyspnea is the most dramatic complication.Severe respiratory difficulties may include electrocardiographic frontal QRS axis rightward shift (Rws) and clockwise rotation (Cwr).
This study investigated the predictability of advanced lung tomography findings with QRS axis shift and rotation.
This was a retrospective analysis of 160 patients.The patients were divided into two groups: normal oxygen saturation(SpO2) (NS; n = 80) and low SpO2(LS;n = 80).They were then divided into NS Rws (n = 37), NS leftward shift (Lws; n = 43), LS Rws (n = 40), and LS Lws (n = 40) according to electrocardiographic follow-up findings. These groups were compared in terms of electrocardiographic rotation (Cwr, counterclockwise rotation, or normal transition), tomographic stage (CO-RADS5(advanced)/CO-RADS1-4), electrocardiographic intervals, and laboratory findings
The lung is the most seriously damaged organ in patients with coronavirus disease (COVID-19). In patients with advanced lung involvement, the alveoli are filled with fluid, white blood cells, mucus, and damaged lung cell debris [1].
The electrical position of the heart in the frontal plane is defined as normal, right, left, or northwest quadrant axis deviation, while its position in the horizontal plane is defined as clockwise rotation (Cwr), normal transition, or counterclockwise rotation (Ccwr)[2].
As respiratory disease progresses,rightward shift(Rws) of the frontal QRS axis can result from Cwr of the heart around its longitudinal axis as viewed from the apex, sudden increase in pulmonary vascular resistance causing right ventricle dilatation, or both [3].
Electrocardiographic changes should be monitored intermittently, as this disease progresses rapidly to near 50% mortality within 7-28 days [4].The aim of this study was to investigate whether easily detectable electrocardiographic axis and rotation changes could predict advanced lung involvement[4].
Methods Study design Records of 250 hospitalized patients with dyspnea and COVID-19 were analyzed retrospectively.Patients were excluded if they received positive pressurized oxygen therapy(n:25),underwent mechanical ventilation,(n:15)exhibited atrial fibrillation(n:10), conditions precluding the assessment of QRS transitional rotation ;complete bundle branch block(n:10), significant arrhythmias(n:5,complete atrioventricular block(n:2), polymorphic ventricular tachycardia(n:2), and ventricular fibrillation), Wolff-Parkinson-White syndrome(n:1), supraventricular tachycardia(n:4), or had unclear QRS axis orientation(n:20). The remaining160 patients who had electronic medical records, nursing records,at least three electrocardiographic recordings taken a few days apart, and laboratory and tomographic findings were included in the study.Patients with normal oxygen saturation (SpO2; ≥ 90%) who did not receive oxygen therapy and patients with low SpO2(\<90%) who received nasal oxygen therapy were included in this study. Patients were divided into two groups: normal SpO2(NS,n = 80) and low SpO2(LS, n = 80).
Electrocardiographic measurements were performed as previously described.The Tpe (T peak to T end) interval was measured from precordial leads [5].The delta corrected QT interval(QTc) calculated as last electrocardiographic QTc minus first electrocardiographic QTc. Discrepancies between computerized electrocardiographic analysis and the mean of three computer-aided measurements(Adobe Photoshop program-300dpi resolution) by a researcher were resolved by consultation with a second researcher.
Using follow-up electrocardiography,according to the direction of QRS axis shift between the first and last electrocardiograms, both groups were divided into two main subgroups:patients with rightward shift (Rws) and patients with leftward shift(Lws) of the QRS axis.The patient numbers were as follows: NS Rws (n=37),NS Lws(n=43),LS Rws (n=40),andLS Lws (n=40). Based on electrocardiographic follow-up analyses,the two main groups were compared in terms of rotation condition (i.e., Cwr, normal transition, or CCwr), electrocardiographic intervals, and laboratory findings
Tomographic findings were evaluated in accordance with COVID-19 Reporting and Data System (CO-RADS)classification.CO-RADS scores are as follows: 1 (very low level of suspicion), 2 (low level of suspicion), 3 (equivocal), 4 (high level of suspicion),and 5 (very high level of suspicion)[6].
Hospitalized patients with dyspnea and COVID-19
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hospitalized patients with dyspnea and COVID-19
Exclusion Criteria:
Patients who received positive pressurized oxygen therapy Patients who underwent mechanical ventilation, Atrial fibrillation Complete bundle branch block Significant arrhythmias(complete atrioventricular block, polymorphic ventricular tachycardia, and ventricular fibrillation), Wolff-Parkinson-White syndrome, supraventricular tachycardia Unclear QRS axis orientation.
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Patients with normal oxygen saturation (SpO2; ≥ 90%) who did not receive oxygen therapy and patients with low SpO2(\<90%) who received nasal oxygen therapy were included in this study
Diagnostic Test: Electrocardiography ,Tomographic imaging
Both groups were divided into two main subgroups:patients with Rws and patients with leftward shift(Lws) of the QRS axis.The patient numbers were as follows: NS Rws (n=37),NS Lws(n=43),LS Rws (n=40),andLS Lws (n=40)
Diagnostic Test: Electrocardiography ,Tomographic imaging
Based on electrocardiographic follow-up analyses,the two main groups were compared in terms of rotation condition (i.e., Cwr, normal transition, or CCwr), electrocardiographic intervals, and laboratory findings In our study,CO-RADS5 was considered an advanced tomographic finding(e.g., multifocal ground glass opacities with consolidation, vascular thickening,crazy paving pattern,mixed pattern),while CO-RADS1,2,3, and 4 were considered non-advanced tomographic findings.
Differences in the electrocardiographic QRS axis shift(°),
Differences in the axis shift between the Rws and Lws groups in patients with NS /LS groups.
Time frame: 10-15 days
Differences in the electrocardiographic rotation
Differences in clockwise,counterclockwise,normal transition between the groups.
Time frame: 10-15 days
Differences in the CO-RADS5/CO-RADS1-4 ratio
Differences in the CO-RADS5/CO-RADS1-4 ratio between the groups.
Time frame: 10-15 days
Plan to share: No
Ran from Jul 2020 to primary completion in Oct 2020, 2 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Ankara Education and Research Hospital