Cardiovascular Status of Children 5 Years After Kawasaki Disease

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Brief Title

Cardiovascular Status of Children 5 Years After Kawasaki Disease

Official Title

Cardiovascular Status of Children 5 Years After Kawasaki Disease

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.
    

Detailed Description

      All participants will be examined in Medical University Warsaw Children's Hospital.

      Children with history of KD will be recruited from 2 paediatric hospitals in Warsaw and via
      advertisement by Polish support group for parents of children with KD in social media.
      Diagnosis of KD will be verified according to current American Heart Association (AHA)
      guidelines.

      All children after KD will be examined 5 years after IVIG treatment exact to 2 months.

      CAA presence at the time of KD diagnosis will be determined on the basis of medical records,
      after specialist consultation, in accordance to AHA definition. Worst-ever echocardiographic
      picture of coronary arteries will be considered in analysis.

      Healthy age- and sex-matched controls (HC) will be recruited from KD patients' siblings.

      Informed consent will be obtained from the parents of all patients and all HC.

      Assessment of cardiovascular status

      All children included in the study will undergo following tests:

        1. Laboratory tests

           Blood samples will be drawn after over-night fasting. A) 1.6 ml of blood will be
           collected in vacutainer tube with ethylenediaminetetraacetic acid (EDTA), B) 4.9 ml of
           blood will be collected in vacutainer tube with clot-activator, without separation gel
           (serum tube).

           Routine laboratory techniques will be used to measure lipid profile, glucose and
           complete blood count. 1 ml of whole blood will be used for circulating endothelial cells
           (CEC) isolation. CEC will be identified with CD146-immunomagnetic bead extraction based
           on an international consensus standardised protocol. 3 ml of blood will be centrifuged
           at room temperature within 2 h of collection and serum will be stored in separate tubes
           at -70°C until analyzed. Endothelial injury markers: endocan, soluble thrombomodulin,
           vascular endothelial growth factor (VEGF) and soluble E-selectin levels will be measured
           using standardized ELISA assays.

        2. Echocardiography

           Echocardiography (ECHO) will be performed with Philips Epiq 7 ultrasound equipment with
           appropriate transducers by a single specialist supervised by an experienced paediatric
           echocardiographer. All the standard anatomic and physiological imaging will be done.
           Multiple imaging planes and transducer positions will be used for optimal visualization
           of the coronary arteries in all major coronary segments - main stem of left coronary
           artery, anterior interventricular branch, circumflex branch and right coronary artery
           will be measured according to AHA guidelines - internal vessel diameter will be assessed
           from inner edge to inner edge of vessel. The number and location of aneurysms and the
           presence or absence of intraluminal thrombi and stenotic lesions will be evaluated.

           Another evaluation will include assessment of the left ventricular form and function
           (ejection fraction measured by Teicholz and Simpson's method, end-systolic and
           end-diastolic volumes, regional wall motion estimated by M-Mode and speckle tracking
           modes, evaluation of diastolic function in Tissue Doppler Imaging, both systolic and
           diastolic function measured as myocardial performance index - i.e. Tei index), aortic
           root imaging (possible dilatation), valvular function (especially mitral and aortic
           regurgitation assessed in pulsed and color doppler), presence of pericardial effusion.
           All of the parameters will be calculated as Z-scores assessed by the health
           professionals Cardio Z mobile application developed by the experienced Paediatric
           Cardiology Team at Evelina Children's Hospital in London.

        3. Carotid intima media thickness (cIMT)

           cIMT will be evaluated in all subjects by a single experienced specialist using
           13-megahertz (MHz) linear transducer, Aloka Prosound Alpha 6, Hitachi Aloka Medical,
           Mitaka, Japan.

           cIMT will be defined as the mean distance from the leading edge of the lumen-intima
           interface to the leading edge of the media adventitia interface of the far wall,
           approximately 1 cm proximal to the carotid bulb. Six determinations of cIMT [mm], three
           on the left and three on the right side, will be obtained and averaged.

        4. Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV)

           Arterial pulse waveform and aortal pulse wave velocity will be evaluated by the same
           investigator using a Sphygmocor device, AtCor Medical Pty Ltd., Sydney, Australia. All
           pulse wave and velocity measurements will be performed in the sitting position in a
           quiet, temperature-controlled room (20 ± 5°C) after a 5 min rest.

           Peripheral pressure waveforms will be recorded from the radial artery at the right
           wrist, using applanation tonometry. After 20 sequential waveforms had been acquired, a
           validated generalized transfer function will be used to generate the corresponding
           central aortic pressure waveform.

        5. Capillaroscopy

      Capillaroscopy will be performed by trained examiner using Dino-Lite Capillaryscope 200 Pro
      (MEDL4N Pro). The examination will be done in the sitting position, in a
      temperature-controlled room (20 ± 5°C). The examined finger will be positioned on a base
      plate and an immersion oil will be applied on the nail fold. Capillary density, morphology
      and arrangement will be assessed and pictures obtained will be captured and stored through
      DinoCapture 2.0 software.

      All examiners will be unaware of patients' clinical details.
    


Study Type

Observational [Patient Registry]


Primary Outcome

CEC in children 5 years after KD

Secondary Outcome

 Left ventricle size in children 5 years after KD

Condition

Vasculitis, Systemic


Study Arms / Comparison Groups

 Kawasaki Disease (KD)
Description:  Children 5 years after Kawasaki Disease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

124

Start Date

January 1, 2019

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility 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.
      

Gender

All

Ages

5 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

Ernest Kuchar, Professor, +48503065849, [email protected]

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT03750123

Organization ID

CAVASAKI


Responsible Party

Principal Investigator

Study Sponsor

Medical University of Warsaw


Study Sponsor

Ernest Kuchar, Professor, Study Chair, Medical University of Warsaw


Verification Date

November 2019