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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with MP pulse | Experimental | Selected participants will be given MP pulse treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone Injection | Drug | methylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body weight in Kilogram | 24 weeks from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho-Chang Kuo, MD; PhD | Contact | +886-7-7317123 | 8320 | erickuo48@yahoo.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
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| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| D003323 | Coronary Aneurysm |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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single arm, phase 1 study of methylprednisolone pulse therapy safety in treatment of aneurysm or coronary artery dilation of Kawasaki disease.
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|
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of body height in centimeter | 24 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of blood pressure & intraocular pressure in mmHg | 24 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Sodium, Potassium, Chlorine level in blood in MEQ/L | 24 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of Calcium & Fibrinogen level in blood in mg/dl | 24 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of prothrombin time & activated partial thromboplastin time in second | 24 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 4 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 8 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 12 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 16 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 20 weeks from enrollment |
| Incidence of Treatment-Emergent Adverse Events and physical effects of Methylprednisolone pulse therapy in Kawasaki disease patients with coronary artery aneurysms | Measurement of protein C & protein S level in ％ | 24 weeks from enrollment |
| 4 weeks from enrollment |
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. | 8 weeks from enrollment |
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. | 12 weeks from enrollment |
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. | 16 weeks from enrollment |
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. | 20 weeks from enrollment |
| Echocardiography on the coronary artery lesion of Kawasaki disease | Use echocardiography to measure the diameter of coronary artery (including right coronary artery [RCA], left coronary artery [LCA] and left anterior descending [LAD]) to investigate the regression of coronary artery dilatation or aneurysm formation. The dilatation is define the diameter of coronary artery. For children under 5 yrs, the diameter should not be wider than 3mm. For children over 5 yrs, the diameter should not be wider than 4mm. Adjacent segment artery should not be wider than 1.5 times. | 24 weeks from enrollment |
| D006425 |
| Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D000783 | Aneurysm |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |