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Covid19NCT04698083

Electrocardiographic QRS Axis Shift ,Rotation and COVİD-19

An observational study of Covid19, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid19
What is being tested?
Electrocardiography ,Tomographic imaging
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jul 2020to 5 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Hospitalized patients with dyspnea and COVID-19

Who may be able to join

  • Hospitalized patients with dyspnea and COVID-19

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Şahbender Koç

    Ankara, 06530

Other trials in Turkey (Türkiye)

About this study

Official title: Retrospective Evaluation of Electrocardiographic Findings of Right Ventricular Overload in Covid 19 Patients With Respiratory Distress

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

Read the detailed description

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].

Conditions
Covid19
Being tested
Electrocardiography ,Tomographic imaging
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrocardiography ,Tomographic imagingDiagnostic test

    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.

Study groups in NCT04698083
Study groupRoleWhat they receive
Group1:normal SpO2(NS,n = 80) and low SpO2(LS, n = 80).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
Receives: Diagnostic Test: Electrocardiography ,Tomographic imaging
Group2:Rightward axis shift(Rws) and Leftward axis shift (Lws)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)
Receives: Diagnostic Test: Electrocardiography ,Tomographic imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in the electrocardiographic QRS axis shift(°),

    Differences in the axis shift between the Rws and Lws groups in patients with NS /LS groups.

    Measured: 10-15 days

  2. Differences in the electrocardiographic rotation

    Differences in clockwise,counterclockwise,normal transition between the groups.

    Measured: 10-15 days

  3. Differences in the CO-RADS5/CO-RADS1-4 ratio

    Differences in the CO-RADS5/CO-RADS1-4 ratio between the groups.

    Measured: 10-15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start22 Jul 2020
  3. Primary completion15 Oct 2020
  4. Study completion5 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04698083
Sponsor's protocol ID
22/7/2020-2152
Status last verified
Jan 2021
First submitted
4 Jan 2021
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Koc S, Bozkaya VO, Yikilgan AB. Electrocardiographic QRS axis shift, rotation and COVID-19. Niger J Clin Pract. 2022 Apr;25(4):415-424. doi: 10.4103/njcp.njcp_9_21.

    PubMed 35439899

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in the electrocardiographic QRS axis shift(°), (time frame: 10-15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04698083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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