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

NCT05205642 | Unknown

• 1 other identifier: 0768-20-RMB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19; MIS-C Associated With COVID-19

Keywords

Cardiopulmonary Exercise Testing; EndoPAT; COVID-19

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

  Measured continuously during 15 minutes of the exercise test (CPET)

Secondary Outcomes (3)

• Six minute walk test (6MWT)

  Six minutes

• Endothelin level

  Five minutes for the blood to be drawn.

• Echocardiography

  Ten minutes.

Study Arms (1)

Patients recovering from COVID-19

EXPERIMENTAL

Pediatric and adult patients recovering from COVID-19 with or without complaints.

Device: Cardiopulmonary exercise test (CPET); Device: Peripheral Arterial Tonography (PAT) using the EndoPAT™ device; Diagnostic Test: Endothelin

Interventions

Cardiopulmonary exercise test (CPET) DEVICE

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.

Patients recovering from COVID-19

Peripheral Arterial Tonography (PAT) using the EndoPAT™ device 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.

Patients recovering from COVID-19

Endothelin DIAGNOSTIC_TEST

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

Patients recovering from COVID-19

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 5 years and older recovering from COVID-19 infection.
• For EndoPAT assessment-at least 3 months since the patient was diagnosed with COVID -19 infection or with PIMS

You may not qualify if:

• Cardiac or pulmonary comorbidity other than COVID-19 related morbidity.
• Inability to perform all study assessments. If a patient will be able to complete one of the assessments or more, the data will be collected and included in the analysis.
• Intercurrent systemic conditions or illness and/or medication use that could affect cardiopulmonary exercise capacity or EndoPAT™.

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• The Baruch Padeh Medical Center, Poriya: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Ronen Bar-Yoseph, MD

CONTACT

+972-4-777-4360; r_bar-yoseph@rambam.health.gov.il

Merav Zucker-Toledano, MD

CONTACT

+972-4-777-4630; M_ZUCKER@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: January 25, 2022
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

IL (1)