Clinical trial NCT06097403: Cardiovascular Complications in Children With COVID 19
Official title: Prevalance of Cardiovascular Complications in Children With COVID 19 in Assuit University Children Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COVID 19 Associated Coagulopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with covid 19 confirmed with PCR from January 2023 till 31 december 2023

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

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

Eligibility criteria: Inclusion Criteria:

* Patient less than 18 years old Presented with COVID 19

Exclusion Criteria:

* Not presented with covid19

Primary outcomes:
measure: Prevalance of cardiovascular complications in children with COVID 19
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.