Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage of the regression of coronary artery lesion (CAL) at one month of illness |
The regression of CAL is defined as z < 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1):60-74). |
at one month of illness |
|
Secondary |
Percentage of the need for additional treatment |
Participants who have recurrent or persistent fever (axillary temperature =37.5°C or rectal temperature =38°C) after 36 hours of completion of initial IVIG infusion will be given additional treatment, including a second dose of IVIG (2 g/kg), or a high dose of methylprednisolone (10 to 30 mg/kg per day), or other immunosuppressive agents such as ciclosporin and cyclophosphamide, or a combination with two or more drugs, or even more aggressive treatment such as plasmapheresis, depending on patients'condition and physicians' experience. Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. |
from admission to discharge (about 2 weeks of illness) |
|
Secondary |
z scores of LMCA throughout the study period |
This is a repeated measurement. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1): 60-74.). The internal diameter of LMCA will be measured by echocardiography at least seven time points: at enrollment, at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of illness. |
from admission to 12 months of illness |
|
Secondary |
z scores of LAD throughout the study period |
This is a repeated measurement. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1): 60-74.). The internal diameter of LAD will be measured by echocardiography at least seven time points: at enrollment, at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of illness. |
from admission to 12 months of illness |
|
Secondary |
z scores of LCX throughout the study period |
This is a repeated measurement. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1): 60-74.). The internal diameter of LCX will be measured by echocardiography at least seven time points: at enrollment, at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of illness. |
from admission to 12 months of illness |
|
Secondary |
z scores of the proximal segment of RCA throughout the study period |
This is a repeated measurement. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1): 60-74.). The internal diameter of the proximal segment of RCA will be measured by echocardiography at least seven time points: at enrollment, at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of illness. |
from admission to 12 months of illness |
|
Secondary |
z scores of the middle segment of RCA throughout the study period |
This is a repeated measurement. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1): 60-74.). The internal diameter of the middle segment of RCA will be measured by echocardiography at least seven time points: at enrollment, at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of illness. |
from admission to 12 months of illness |
|
Secondary |
Duration of fever (hours) after initiation of initial IVIG infusion |
Participants with an axillary temperature <37.5? (or rectal temperature <38?) for more than 24 hours are considered afebrile. Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal. |
from initiation of initial IVIG infusion to the first record of being afebrile (defined as an axillary temperature <37.5 for more than 24 hours) |
|
Secondary |
Change in serum C-reactive protein (CRP) concentration |
CRP level is measured before initial IVIG infusion and 72 hours after completion of initial IVIG infusion.Change would be described by difference. |
from admission to 72 hours after completion of initial IVIG infusion |
|
Secondary |
Number of patients with serious adverse events |
This is a composite outcome, including death, hypertension (defined as the blood pressure (BP) =90th percentile for age and height or = 120/80 mmHg in the children younger than 13, and = 120/80 mmHg in children = 13 years), severe infection (such as septicopyemia, pulmonary infection and urinary system infection), allergic reactions, heart failure, thrombosis, etc. |
from admission to 12 months of illness |
|
Secondary |
Percentage of the regression of coronary artery lesion (CAL) at 3 months of illness |
The regression of CAL is defined as the z < 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. |
at 3 months of illness |
|
Secondary |
Percentage of the regression of coronary artery lesion (CAL) at 6 months of illness |
The regression of CAL is defined as the z < 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. |
at 6 months of illness |
|
Secondary |
Percentage of the regression of coronary artery lesion (CAL) at 9 months of illness |
The regression of CAL is defined as the z < 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. |
at 9 months of illness |
|
Secondary |
Percentage of the regression of coronary artery lesion (CAL) at 12 months of illness |
The regression of CAL is defined as the z < 2 of all coronary arteries of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. |
at 12 months of illness |
|