Cardiovascular Status of Children 5 Years After Kawasaki Disease

NCT03750123 | Completed

• 1 other identifier: CAVASAKI
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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, galectin-3, soluble VCAM), peripheral blood pressure, central blood pressure, arterial stiffness parameters (measured by applanation tonometry), carotid intima media thickness (cIMT), capillaroscopy and echocardiography.

Conditions

Vasculitis, Systemic; Kawasaki Disease

Keywords

kawasaki; arterial stiffness; PWV; cIMT; galectin-3

Outcome Measures

Primary Outcomes (3)

• CEC in children 5 years after KD

  comparison of CEC number in KD and HC groups

  5 years

• Arterial stiffness in children 5 years after KD

  comparison of pulse wave velocity Z-score in KD and HC groups

  5 years

• Central blood pressure in children 5 years after KD

  comparison of central blood pressure values in KD and HC groups

  5 years

Secondary Outcomes (8)

• Left ventricle size in children 5 years after KD

  5 years

• Diastolic function of the left ventricle in children 5 years after KD

  5 years

• cIMT in children 5 years after KD

  5 years

• Capillaroscopy in children 5 years after KD

  5 years

• Endocan in children 5 years after KD

  5 years

Study Arms (2)

Kawasaki Disease (KD)

Children 5 years after Kawasaki Disease

Healthy controls (HC)

Age- and sexmatched healthy siblings of children after Kawasaki Disease

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• history of KD treated with intravenous immunoglobulin (IVIG)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw Children's Hospital

Warsaw, 02-091, Poland

Location

Related Publications (3)

• 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.

  PMID: 28356445 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

MeSH Terms

Conditions

Systemic Vasculitis; Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ernest Kuchar, Professor

  Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 21, 2018
• Study Start: January 1, 2019
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

PL (1)