Exercise Fatigue Parameters and Endothelial Function in Pediatric Patients With a History of COVID-19 Infection or MIS-C

Summary

Acute coronavirus disease 2019 (COVID-19) infection can include cardiac and pulmonary manifestations as well as post-infectious complications such as multisystem inflammatory syndrome (MIS-C), also known as pediatric inflammatory multisystem syndrome (PIMS / PIMS-TS). The precise etiology for COVID-19 symptoms and MIS-C is still obscure but there is evidence that endothelial damage may play a role. At recovery, symptoms such as dyspnea, fatigue, weakness, myalgia, chest pain and palpitations are prevalent. Data regarding functional capacity, cardiopulmonary and vascular function post COVID-19 infection are scarce. To the best of our knowledge, few studies has evaluated functional capacity of patients recovering from COVID-19 infection and complications using cardiopulmonary exercise testing (CPET), and no study included endothelial function assessment.

Aims I. To investigate the effect of COVID-19 infection on cardiovascular and pulmonary function and exercise parameters in the pediatric and adult population.

II. To investigate the effect of PIMS on endothelial function in pediatric population.

Research hypothesis:

1. After COVID-19 infection, aerobic function is impaired due to cardiac and/or pulmonary limitation
2. Endothelial function in children after PIMS is impaired in comparison to healthy individuals and to patients after COVID infection with mild symptoms.

Importance of the study: Cardiovascular and pulmonary assessment of patients recovering from COVID-19 infection using CPET and Peripheral Arterial Tonography (EndoPAT™) has not been reported previously, and will provide new insights into the long term significance of COVID-19 infection.

Conditions

• COVID-19
• MIS-C Associated With COVID-19

Interventions

DEVICE

Cardiopulmonary exercise test (CPET)

Cardiopulmonary exercise testing (CPET) using a Quark CPET metabolic cart (Rome, Italy) according to American Thoracic Society (ATS) guidelines. A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute) adapted to the patient's functional capacities according to the examiner's free judgment, up to exhaustion.

DEVICE

Peripheral Arterial Tonography (PAT) using the EndoPAT™ device

A volume sensor measuring reactive hyperemia is placed on the second fingertip of both hands. First the device evaluates the baseline volume of the pulse. Then, we will apply pressure that is 50 mmHg higher than the baseline systolic pressure of the examinee on the evaluated hand for five minutes, using a sphygmomanometer cuff. After the pressure is released on the evaluated hand, the new pulse volume is tested. To neutralize the effects of the autonomous systemic response, the program divides the difference of the pulse volume in the examined hand by the difference in the untested hand and we get the Reactive Hyperemic Index (RHI) which represents the endothelial function in the tested hand. During the examination, the calculated arterial tonometry graph is generated, and out of it the RHI will be automatically calculated, using the EndoPAT2000™ program.

DIAGNOSTIC_TEST

Endothelin

For Endothelin levels we will use the Endothelin ELISA kit from R\&D company, and for measurement 1 cc of serum will be needed.

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya

  collaborator OTHER_GOV

• Rambam Health Care Campus

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2023-12-31

Completion

2024-06-30

Countries

• Israel

Study Locations