Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease

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Brief Title

Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease

Official Title

Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease

Brief Summary

      In this study, the investigator plan to prescribe Methylprednisolone pulse therapy in
      Kawasaki disease patients with coronary artery lesions or aneurysm formation beyond acute
      stage to investigate the role for vasculitis of KD or regression of dilatation.

Detailed Description

      Kawasaki disease is the most common systemic vasculitis in children. Coronary artery
      aneurysms may develop in 20-25% of untreated patients. Intravenous immune globulin (IVIG) can
      reduce coronary-artery aneurysms to 3-5%. Numerous studies and clinical trials had pointed
      out that corticosteroid treatment (pulse therapy or not) could lower the incidence of
      coronary artery abnormality in high-risk KD patients. However, the therapeutic effect of
      corticosteroid in KD patients with aneurysm formation after acute stage was never mentioned.
      There is no effective treatment for aneurysm formation available in KD after acute stage.
      Methylprednisolone pulse therapy (MP pulse) was used for treatment of KD during acute stage
      since more than 20 years ago. MP pulse plus IVIG seems not benefit for KD patients but
      benefit for IVIG resistant KD patients or for high-risk group of CAL formation/ IVIG
      resistance group. MP pulse therapy is well document used in autoimmune disease vasculitis
      such as SLE, rheumatoid arthritis, dermatomyosis...etc. Taking together, MP pulse is
      effective and safe for KD patients during acute stage. In this study, the investigators plan
      to use MP pulse in KD patients with CAL or aneurysm formation beyond acute stage to
      investigate the role of vasculitis of KD or regression of dilatation.

      Methods: The investigators conducted a prospective study of methylprednisolone pulse therapy
      (MP pulse) for KD patients with coronary aneurysm or dilatation formation. The investigators
      will enroll these patients to receive methylprednisolone pulse (MP pulse, 30mg/kg, Max:1g/day
      for continue 3 days) for treatment. Together with other anti-inflammatory oral medicine
      including monteleukast, Dextromethorphan(DXM), prednisolone, and ketotifen as supplementary
      treatment.

      The specific aim of this study is the regression of coronary artery aneurysm after MP pulse
      therapy.

      Under the hypothesis and specific aim, the investigators plan to do in the following 3 years:

        1. During the 1st year, the investigators will enroll for 5-10 cases for safety surveys
           including blood pressure monitoring, inflammatory markers, liver function, renal
           function, electrolyte imbalance, growth problems as Phase I study.

        2. In the 2nd and 3rd year of this study, the investigators will enroll for 20-30 cases for
           an effective survey as Phase II study.

      Results from this study will help clinicians to treat aneurysm formation or coronary artery
      dilatation in KD patients and reduce the activity limitation of patients, reduce the medical
      resource in those patients. The investigators may provide the first treatment for aneurysm in
      KD.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms

Secondary Outcome

 Echocardiography on the coronary artery lesion of Kawasaki disease

Condition

Mucocutaneous Lymph Node Syndrome

Intervention

Methylprednisolone Injection

Study Arms / Comparison Groups

 Participants treated with MP pulse
Description:  Selected participants will be given MP pulse treatment

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

10

Start Date

April 15, 2020

Completion Date

August 31, 2023

Primary Completion Date

April 15, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Kawasaki disease patients with coronary artery dilation or aneurysm formation after
             acute stage (at lease 3 weeks after IVIG treatment)

        Exclusion Criteria:

          -  patients meet the contraindications of Methylprednisolone sodium succinate, e.g.,
             allergic to Methylprednisolone sodium succinate, premature infant, immune system
             related thrombocytopathy, immunodeficiency, any congenital diseases.

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

, +886-7-7317123, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT04509219

Organization ID

MP pulse in KD

Responsible Party

Sponsor

Study Sponsor

Chang Gung Memorial Hospital

Study Sponsor

, ,

Verification Date

May 2020