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Cardiovascular Status of Children 5 Years After Kawasaki Disease (CAVASAKI)

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ClinicalTrials.gov Identifier: NCT03750123
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Magdalena Okarska-Napierała, Medical University of Warsaw

Brief Summary:

The aim of present study is to determine cardiovascular status of children who had KD in past and to identify possible biochemical markers of cardiovascular damage in those patients.

In this cross-sectional study children with history of KD will be examined 5 years after receiving intravenous immunoglobulin treatment (IVIG) and compared to healthy controls in terms of: serum levels of endothelial injury markers (circulating endothelial cells, endocan, soluble thrombomodulin, vascular endothelial growth factor (VEGF) and soluble E-selectin), peripheral blood pressure, central blood pressure, arterial stiffness parameters (measured by applanation tonometry), carotid intima media thickness (cIMT), capillaroscopy and echocardiography.


Condition or disease
Vasculitis, Systemic Kawasaki Disease

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 124 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: Cardiovascular Status of Children 5 Years After Kawasaki Disease
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

Group/Cohort
Kawasaki Disease (KD)
Children 5 years after Kawasaki Disease
Healthy controls (HC)
Age- and sexmatched healthy siblings of children after Kawasaki Disease



Primary Outcome Measures :
  1. CEC in children 5 years after KD [ Time Frame: 5 years ]
    comparison of CEC number in KD and HC groups

  2. Arterial stiffness in children 5 years after KD [ Time Frame: 5 years ]
    comparison of pulse wave velocity Z-score in KD and HC groups

  3. Central blood pressure in children 5 years after KD [ Time Frame: 5 years ]
    comparison of central blood pressure values in KD and HC groups


Secondary Outcome Measures :
  1. Left ventricle size in children 5 years after KD [ Time Frame: 5 years ]
    comparison of left ventricle mass index in KD and HC groups

  2. Diastolic function of the left ventricle in children 5 years after KD [ Time Frame: 5 years ]
    comparison of E/A ratio in KD and HC groups

  3. cIMT in children 5 years after KD [ Time Frame: 5 years ]
    comparison of cIMT thickness in KD and HC groups

  4. Capillaroscopy in children 5 years after KD [ Time Frame: 5 years ]
    comparison of capillary characteristics (normal / not-normal) in KD and HC groups

  5. Endocan in children 5 years after KD [ Time Frame: 5 years ]
    comparison of endocan serum concentration in KD and HC groups

  6. Thrombomodulin in children 5 years after KD [ Time Frame: 5 years ]
    comparison of thrombomodulin serum concentration in KD and HC groups

  7. VEGF in children 5 years after KD [ Time Frame: 5 years ]
    comparison of VEGF serum concentration in KD and HC groups

  8. Soluble E-selectin in children 5 years after KD [ Time Frame: 5 years ]
    comparison of soluble E-selectin serum concentration in KD and HC groups


Biospecimen Retention:   Samples Without DNA
3 ml of blood will be centrifuged and serum will be stored in separate tubes at − 70°C until analyzed


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 5 years after Kawasaki Disease will be recruited from 2 Warsaw hospitals and via advertisment by Polish support group for parents of children with KD in social media
Criteria

Inclusion Criteria:

  • history of KD treated with intravenous immunoglobulin (IVIG)

Exclusion Criteria:

  • any significant comorbidities,
  • body mass index (BMI) value > 1 standard deviation (SD) for age and gender,
  • height < 120 cm at the time of cardiovascular assessment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750123


Contacts
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Contact: Magdalena Okarska-Napierała, PhD +48503065849 magda.okarska@gmail.com

Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Ernest Kuchar, Professor Medical University of Warsaw

Additional Information:

Publications of Results:
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Responsible Party: Magdalena Okarska-Napierała, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03750123     History of Changes
Other Study ID Numbers: CAVASAKI
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Magdalena Okarska-Napierała, Medical University of Warsaw:
kawasaki
arterial stiffness
PWV
cIMT

Additional relevant MeSH terms:
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Vasculitis
Mucocutaneous Lymph Node Syndrome
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases