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COVID 19 Associated CoagulopathyNCT06097403

Cardiovascular Complications in Children With COVID 19

An observational study of COVID 19 Associated Coagulopathy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prevalance of cardiovascular complications in children with COVID 19 in Assuit university children hospital Read more about this study

Who is it for?
Ages 1 day to 18 years
Conditions the study is for
COVID 19 Associated Coagulopathy
What is being tested?
Covid 19 swap
How many people
100 participants
Where
No sites listed yet
Study dates
Oct 2023to Oct 2024
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 1 day to 18 years
  • All sexes
  • Child, Adult

Study population: All patients with covid 19 confirmed with PCR from January 2023 till 31 december 2023

Who may be able to join

  • Patient less than 18 years old Presented with COVID 19

Who cannot join

  • Not presented with covid19

About this study

Official title: Prevalance of Cardiovascular Complications in Children With COVID 19 in Assuit University Children Hospital

Prevalance of cardiovascular complications in children with COVID 19 in Assuit university children hospital

Read the detailed description

In December 2019, coronavirus disease 2019 (COVID-19) was first described in Wuhan, China, in patients complaining of flulike symptoms.1 The virus was isolated and identified as a new strain of coronavirus, now named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 ) . Cardiovascular complications of COVID-19 have received less medical attention; nevertheless, the first cases of myocarditis in COVID-19 patients have been reported,3, 4, 5, 6 and myocarditis has been recognized as the cause of death in some covid 19 patients.7 Pathology usually is focal within the myocardium, but there is a risk of arrhythmia as well as progression to fulminant heart failure and cardiogenic shock.

Clinical presentation of SARS-CoV-2 myocarditis varies among cases. Some patients may present with relatively mild symptoms, such as fatigue and dyspnea,4 , 5 whereas others report chest pain or chest tightness on exertion.3 , 6 Many patients do deteriorate, showing symptoms of tachycardia and acute-onset heart failure with cardiogenic shock.3, 4, 5 In these severe cases, patients may also present with signs of right-sided heart failure, including raised jugular venous pressure, peripheral edema, and right upper quadrant pain.10 The most emergent presentation is fulminant myocarditis, defined as ventricular dysfunction and heart failure within 2-3 weeks of contracting the virus.8 The early signs of fulminant myocarditis usually resemble those of sepsis: the patient often presents febrile with low pulse pressure, cold or mottled extremities, and sinus tachycardia.10 Myocarditis is an inflammatory disease of the heart characterized by inflammatory infiltrates and myocardial injury without an ischemic cause.8 The most commonly identifiable cause of myocarditis in the United States and other developed countries is viral.9 , Arrhythmia is recognized as one of the possible clinical manifestations of COVID-19 patients. One observational study of the clinical characteristics of COVID-19 patients in Hubei, China, reported a 7.3% incidence of heart palpitations among its 137 patients 13 Moreover, Wang et al reported that arrhythmia was a cause of intensive care unit transfer in 44.4% of COVID- Coagulation and inflammatory parameters are mildly altered in COVID-19 infection, whereas MIS-C is characterized by laboratory evidence of a proinflammatory and procoagulant state

Being tested
Covid 19 swap

What participants receive

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

  • Covid 19 swapDiagnostic test

    diagnostic tool

What is being measured

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

  1. Prevalance of cardiovascular complications in children with COVID 19

    estimate the prevalence of cardiovascular complications among pediatric patients with covid 19 in Isolation Unit , Chest unit , and Cardiology unit in Assiut University Children Hospital

    Measured: Baseline

Timeline

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

  1. First posted24 Oct 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

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-control
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097403
Sponsor's protocol ID
cardiovascular complications
Status last verified
Oct 2023
First submitted
22 Oct 2023
Last updated
24 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Das BB, Akam-Venkata J, Abdulkarim M, Hussain T. Parametric Mapping Cardiac Magnetic Resonance Imaging for the Diagnosis of Myocarditis in Children in the Era of COVID-19 and MIS-C. Children (Basel). 2022 Jul 16;9(7):1061. doi: 10.3390/children9071061.

    PubMed 35884045

Questions about this trial

What is this clinical trial studying?

An observational study of COVID 19 Associated Coagulopathy, run by Assiut University.

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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Prevalance of cardiovascular complications in children with COVID 19 (time frame: Baseline). 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 NCT06097403, 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 24 Oct 2023.

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