Mucocutaneous Lymph Node Syndrome Clinical Trial
Official title:
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00841789 -
A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
|
Phase 2 | |
| Completed |
NCT03880929 -
Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
|
||
| Completed |
NCT00000520 -
Prevention of Coronary Aneurysms in Kawasaki Syndrome
|
Phase 2 | |
| Completed |
NCT03065244 -
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
|
Phase 3 |