<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750123</url>
  </required_header>
  <id_info>
    <org_study_id>CAVASAKI</org_study_id>
    <nct_id>NCT03750123</nct_id>
  </id_info>
  <brief_title>Cardiovascular Status of Children 5 Years After Kawasaki Disease</brief_title>
  <acronym>CAVASAKI</acronym>
  <official_title>Cardiovascular Status of Children 5 Years After Kawasaki Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of present study is to determine cardiovascular status of children who had KD in past&#xD;
      and to identify possible biochemical markers of cardiovascular damage in those patients.&#xD;
&#xD;
      In this cross-sectional study children with history of KD will be examined 5 years after&#xD;
      receiving intravenous immunoglobulin treatment (IVIG) and compared to healthy controls in&#xD;
      terms of: serum levels of endothelial injury markers (circulating endothelial cells, endocan,&#xD;
      soluble thrombomodulin, vascular endothelial growth factor (VEGF) and soluble E-selectin),&#xD;
      peripheral blood pressure, central blood pressure, arterial stiffness parameters (measured by&#xD;
      applanation tonometry), carotid intima media thickness (cIMT), capillaroscopy and&#xD;
      echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will be examined in Medical University Warsaw Children's Hospital.&#xD;
&#xD;
      Children with history of KD will be recruited from 2 paediatric hospitals in Warsaw and via&#xD;
      advertisement by Polish support group for parents of children with KD in social media.&#xD;
      Diagnosis of KD will be verified according to current American Heart Association (AHA)&#xD;
      guidelines.&#xD;
&#xD;
      All children after KD will be examined 5 years after IVIG treatment exact to 2 months.&#xD;
&#xD;
      CAA presence at the time of KD diagnosis will be determined on the basis of medical records,&#xD;
      after specialist consultation, in accordance to AHA definition. Worst-ever echocardiographic&#xD;
      picture of coronary arteries will be considered in analysis.&#xD;
&#xD;
      Healthy age- and sex-matched controls (HC) will be recruited from KD patients' siblings.&#xD;
&#xD;
      Informed consent will be obtained from the parents of all patients and all HC.&#xD;
&#xD;
      Assessment of cardiovascular status&#xD;
&#xD;
      All children included in the study will undergo following tests:&#xD;
&#xD;
        1. Laboratory tests&#xD;
&#xD;
           Blood samples will be drawn after over-night fasting. A) 1.6 ml of blood will be&#xD;
           collected in vacutainer tube with ethylenediaminetetraacetic acid (EDTA), B) 4.9 ml of&#xD;
           blood will be collected in vacutainer tube with clot-activator, without separation gel&#xD;
           (serum tube).&#xD;
&#xD;
           Routine laboratory techniques will be used to measure lipid profile, glucose and&#xD;
           complete blood count. 1 ml of whole blood will be used for circulating endothelial cells&#xD;
           (CEC) isolation. CEC will be identiﬁed with CD146-immunomagnetic bead extraction based&#xD;
           on an international consensus standardised protocol. 3 ml of blood will be centrifuged&#xD;
           at room temperature within 2 h of collection and serum will be stored in separate tubes&#xD;
           at -70°C until analyzed. Endothelial injury markers: endocan, soluble thrombomodulin,&#xD;
           vascular endothelial growth factor (VEGF) and soluble E-selectin levels will be measured&#xD;
           using standardized ELISA assays.&#xD;
&#xD;
        2. Echocardiography&#xD;
&#xD;
           Echocardiography (ECHO) will be performed with Philips Epiq 7 ultrasound equipment with&#xD;
           appropriate transducers by a single specialist supervised by an experienced paediatric&#xD;
           echocardiographer. All the standard anatomic and physiological imaging will be done.&#xD;
           Multiple imaging planes and transducer positions will be used for optimal visualization&#xD;
           of the coronary arteries in all major coronary segments - main stem of left coronary&#xD;
           artery, anterior interventricular branch, circumflex branch and right coronary artery&#xD;
           will be measured according to AHA guidelines - internal vessel diameter will be assessed&#xD;
           from inner edge to inner edge of vessel. The number and location of aneurysms and the&#xD;
           presence or absence of intraluminal thrombi and stenotic lesions will be evaluated.&#xD;
&#xD;
           Another evaluation will include assessment of the left ventricular form and function&#xD;
           (ejection fraction measured by Teicholz and Simpson's method, end-systolic and&#xD;
           end-diastolic volumes, regional wall motion estimated by M-Mode and speckle tracking&#xD;
           modes, evaluation of diastolic function in Tissue Doppler Imaging, both systolic and&#xD;
           diastolic function measured as myocardial performance index - i.e. Tei index), aortic&#xD;
           root imaging (possible dilatation), valvular function (especially mitral and aortic&#xD;
           regurgitation assessed in pulsed and color doppler), presence of pericardial effusion.&#xD;
           All of the parameters will be calculated as Z-scores assessed by the health&#xD;
           professionals Cardio Z mobile application developed by the experienced Paediatric&#xD;
           Cardiology Team at Evelina Children's Hospital in London.&#xD;
&#xD;
        3. Carotid intima media thickness (cIMT)&#xD;
&#xD;
           cIMT will be evaluated in all subjects by a single experienced specialist using&#xD;
           13-megahertz (MHz) linear transducer, Aloka Prosound Alpha 6, Hitachi Aloka Medical,&#xD;
           Mitaka, Japan.&#xD;
&#xD;
           cIMT will be defined as the mean distance from the leading edge of the lumen-intima&#xD;
           interface to the leading edge of the media adventitia interface of the far wall,&#xD;
           approximately 1 cm proximal to the carotid bulb. Six determinations of cIMT [mm], three&#xD;
           on the left and three on the right side, will be obtained and averaged.&#xD;
&#xD;
        4. Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV)&#xD;
&#xD;
           Arterial pulse waveform and aortal pulse wave velocity will be evaluated by the same&#xD;
           investigator using a Sphygmocor device, AtCor Medical Pty Ltd., Sydney, Australia. All&#xD;
           pulse wave and velocity measurements will be performed in the sitting position in a&#xD;
           quiet, temperature-controlled room (20 ± 5°C) after a 5 min rest.&#xD;
&#xD;
           Peripheral pressure waveforms will be recorded from the radial artery at the right&#xD;
           wrist, using applanation tonometry. After 20 sequential waveforms had been acquired, a&#xD;
           validated generalized transfer function will be used to generate the corresponding&#xD;
           central aortic pressure waveform.&#xD;
&#xD;
        5. Capillaroscopy&#xD;
&#xD;
      Capillaroscopy will be performed by trained examiner using Dino-Lite Capillaryscope 200 Pro&#xD;
      (MEDL4N Pro). The examination will be done in the sitting position, in a&#xD;
      temperature-controlled room (20 ± 5°C). The examined finger will be positioned on a base&#xD;
      plate and an immersion oil will be applied on the nail fold. Capillary density, morphology&#xD;
      and arrangement will be assessed and pictures obtained will be captured and stored through&#xD;
      DinoCapture 2.0 software.&#xD;
&#xD;
      All examiners will be unaware of patients' clinical details.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>CEC in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of CEC number in KD and HC groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial stiffness in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of pulse wave velocity Z-score in KD and HC groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central blood pressure in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of central blood pressure values in KD and HC groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left ventricle size in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of left ventricle mass index in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic function of the left ventricle in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of E/A ratio in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cIMT in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of cIMT thickness in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capillaroscopy in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of capillary characteristics (normal / not-normal) in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endocan in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of endocan serum concentration in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombomodulin in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of thrombomodulin serum concentration in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VEGF in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of VEGF serum concentration in KD and HC groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble E-selectin in children 5 years after KD</measure>
    <time_frame>5 years</time_frame>
    <description>comparison of soluble E-selectin serum concentration in KD and HC groups</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Vasculitis, Systemic</condition>
  <condition>Kawasaki Disease</condition>
  <arm_group>
    <arm_group_label>Kawasaki Disease (KD)</arm_group_label>
    <description>Children 5 years after Kawasaki Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls (HC)</arm_group_label>
    <description>Age- and sexmatched healthy siblings of children after Kawasaki Disease</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      3 ml of blood will be centrifuged and serum will be stored in separate tubes at - 70°C until&#xD;
      analyzed&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children 5 years after Kawasaki Disease will be recruited from 2 Warsaw hospitals and via&#xD;
        advertisment by Polish support group for parents of children with KD in social media&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of KD treated with intravenous immunoglobulin (IVIG)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any significant comorbidities,&#xD;
&#xD;
          -  body mass index (BMI) value &gt; 1 standard deviation (SD) for age and gender,&#xD;
&#xD;
          -  height &lt; 120 cm at the time of cardiovascular assessment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ernest Kuchar, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Magdalena Okarska-Napierała, PhD</last_name>
    <phone>+48503065849</phone>
    <email>magda.okarska@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Warsaw Children's Hospital</name>
      <address>
        <city>Warsaw</city>
        <zip>02-091</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Magdalena Okarska-Napierała, PhD</last_name>
      <phone>504065849</phone>
      <email>magda.okarska@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29. Erratum In: Circulation. 2019 Jul 30;140(5):e181-e184.</citation>
    <PMID>28356445</PMID>
  </reference>
  <reference>
    <citation>Dietz SM, Tacke CE, Hutten BA, Kuijpers TW. Peripheral Endothelial (Dys)Function, Arterial Stiffness and Carotid Intima-Media Thickness in Patients after Kawasaki Disease: A Systematic Review and Meta-Analyses. PLoS One. 2015 Jul 10;10(7):e0130913. doi: 10.1371/journal.pone.0130913. eCollection 2015.</citation>
    <PMID>26161871</PMID>
  </reference>
  <reference>
    <citation>Shah V, Christov G, Mukasa T, Brogan KS, Wade A, Eleftheriou D, Levin M, Tulloh RM, Almeida B, Dillon MJ, Marek J, Klein N, Brogan PA. Cardiovascular status after Kawasaki disease in the UK. Heart. 2015 Oct;101(20):1646-55. doi: 10.1136/heartjnl-2015-307734. Epub 2015 Aug 27.</citation>
    <PMID>26316045</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Magdalena Okarska-Napierała</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>kawasaki</keyword>
  <keyword>arterial stiffness</keyword>
  <keyword>PWV</keyword>
  <keyword>cIMT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Mucocutaneous Lymph Node Syndrome</mesh_term>
    <mesh_term>Systemic Vasculitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750123
org study id: CAVASAKI
nct id: NCT03750123
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: CEC in children 5 years after KD
time frame: 5 years
description: comparison of CEC number in KD and HC groups
measure: Arterial stiffness in children 5 years after KD
time frame: 5 years
description: comparison of pulse wave velocity Z-score in KD and HC groups
measure: Central blood pressure in children 5 years after KD
time frame: 5 years
description: comparison of central blood pressure values in KD and HC groups
measure: Left ventricle size in children 5 years after KD
time frame: 5 years
description: comparison of left ventricle mass index in KD and HC groups
measure: Diastolic function of the left ventricle in children 5 years after KD
time frame: 5 years
description: comparison of E/A ratio in KD and HC groups
measure: cIMT in children 5 years after KD
time frame: 5 years
description: comparison of cIMT thickness in KD and HC groups
measure: Capillaroscopy in children 5 years after KD
time frame: 5 years
description: comparison of capillary characteristics (normal / not-normal) in KD and HC groups
measure: Endocan in children 5 years after KD
time frame: 5 years
description: comparison of endocan serum concentration in KD and HC groups
measure: Thrombomodulin in children 5 years after KD
time frame: 5 years
description: comparison of thrombomodulin serum concentration in KD and HC groups
measure: VEGF in children 5 years after KD
time frame: 5 years
description: comparison of VEGF serum concentration in KD and HC groups
measure: Soluble E-selectin in children 5 years after KD
time frame: 5 years
description: comparison of soluble E-selectin serum concentration in KD and HC groups
arm group label: Kawasaki Disease (KD)
description: Children 5 years after Kawasaki Disease
arm group label: Healthy controls (HC)
description: Age- and sexmatched healthy siblings of children after Kawasaki Disease
3 ml of blood will be centrifuged and serum will be stored in separate tubes at - 70°C until
      analyzed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 15 Years
healthy volunteers: No
last name: Ernest Kuchar, Professor
role: Study Chair
affiliation: Medical University of Warsaw
last name: Magdalena Okarska-Napierała, PhD
phone: +48503065849
email: magda.okarska@gmail.com
facility: 
status: Recruiting
contact: 
country: Poland
citation: McCrindle BW, Rowley AH, Newburger JW, Burns JC, Bolger AF, Gewitz M, Baker AL, Jackson MA, Takahashi M, Shah PB, Kobayashi T, Wu MH, Saji TT, Pahl E; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Epidemiology and Prevention. Diagnosis, Treatment, and Long-Term Management of Kawasaki Disease: A Scientific Statement for Health Professionals From the American Heart Association. Circulation. 2017 Apr 25;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. Epub 2017 Mar 29. Erratum In: Circulation. 2019 Jul 30;140(5):e181-e184.
PMID: 28356445
citation: Dietz SM, Tacke CE, Hutten BA, Kuijpers TW. Peripheral Endothelial (Dys)Function, Arterial Stiffness and Carotid Intima-Media Thickness in Patients after Kawasaki Disease: A Systematic Review and Meta-Analyses. PLoS One. 2015 Jul 10;10(7):e0130913. doi: 10.1371/journal.pone.0130913. eCollection 2015.
PMID: 26161871
citation: Shah V, Christov G, Mukasa T, Brogan KS, Wade A, Eleftheriou D, Levin M, Tulloh RM, Almeida B, Dillon MJ, Marek J, Klein N, Brogan PA. Cardiovascular status after Kawasaki disease in the UK. Heart. 2015 Oct;101(20):1646-55. doi: 10.1136/heartjnl-2015-307734. Epub 2015 Aug 27.
PMID: 26316045
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Magdalena Okarska-Napierała
investigator title: Principal Investigator
mesh term: Vasculitis
mesh term: Mucocutaneous Lymph Node Syndrome
mesh term: Systemic Vasculitis
sharing ipd: Undecided