Trial · NCT04078568
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of coronary artery lesions(CAL) at one month of illness | at one month of illness | 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).）. CAL is defined as z≥2of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. |
| Secondary | Percentage of the need for additional treatment | from admission to discharge (about 2 weeks of illness) | Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. 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. |
| Secondary | Duration of fever (hours) after initiation of initial IVIG infusion | 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) | Axillary temperature (or rectal temperature) will be measured every 6 hours a day during hospitalization. Participants with an axillary temperature \<37.5℃ (or rectal temperature \<38℃) for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal. |
| Secondary | Changes in z scores of LMCA throughout the study period | from admission to 12 months of illness | This is a repeated measurement. The internal diameter of LMCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）. |
| Secondary | Changes in z scores of LAD throughout the study period | from admission to 12 months of illness | This is a repeated measurement. The internal diameter of LAD will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）. |
| Secondary | Changes in z scores of LCX throughout the study period | from admission to 12 months of illness | This is a repeated measurement. The internal diameter of LCX will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）. |
| Secondary | Changes in z scores of the proximal segment of RCA throughout the study period | from admission to 12 months of illness | This is a repeated measurement. The internal diameter of the proximal segment of RCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）. |
| Secondary | Changes in z scores of the middle segment of RCA throughout the study period | from admission to 12 months of illness | This is a repeated measurement. The internal diameter of the middle segment of RCA will be measured by echocardiography at six time points: at enrolment, at 2 weeks, 1 month, 3 months, 6 months and 12 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter（Journal of the American Society of Echocardiography, 2011, 24(1).）. |
| Secondary | Change in serum C-reactive protein (CRP) concentration | from admission to 72 hours after completion of initial IVIG infusion | CRP level is measured before initial IVIG infusion and 72 hours after completion of initial IVIG infusion. |
| Secondary | Number of patients with serious adverse events | from admission to 3 months of illness | This is a composite outcome, including death, hypertension, severe infection, allergic reactions, heart failure, thrombosis, etc. |
| Secondary | Occurrence of medium-to-giant coronary artery aneurysms (CAAs) | from admission to 12 months of illness onset | Exploratory Outcome. This is a repeatedly measured binary variable. CAL classification is based on the maximum z score according to the 2017 American Heart Association guideline. Medium CAA is defined as a maximum Z score ≥5 to \<10, and all internal diameters \<8 mm; large or giant CAA is defined as a maximum Z score ≥10, or any internal diameter ≥8 mm. Data were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Occurrence of large/giant CAAs | from admission to 12 months of illness onset | Exploratory Outcome. This is a repeatedly measured binary variable. CAL classification is based on the maximum z score according to the 2017 American Heart Association guideline. Medium CAA is defined as a maximum Z score ≥5 to \<10, and all internal diameters \<8 mm; large or giant CAA is defined as a maximum Z score ≥10, or any internal diameter ≥8 mm. Data were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Occurrence of CAL progression within 3 months of illness onset | from admission to 3 months of illness onset | Exploratory outcome. CAL progression is defined as an increment in the Z score ≥1 from admission in any coronary artery (LMCA, LAD, LCX, proximal and middle segments of RCA) at any given time point within 3 months of illness onset. The outcome was assessed in all participants and those with CAL at baseline. |
| Secondary | Changes in absolute diameter of LMCA throughout the study period | from admission to 12 months of illness onset | Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LMCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Changes in absolute diameter of LAD throughout the study period | from admission to 12 months of illness onset | Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LAD were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Changes in absolute diameter of LCX throughout the study period | from admission to 12 months of illness onset | Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of LCX were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Changes in absolute diameter of the proximal segment of RCA throughout the study period | from admission to 12 months of illness onset | Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of the proximal segment of RCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
| Secondary | Changes in absolute diameter of the middle segment of RCA throughout the study period | from admission to 12 months of illness onset | Exploratory outcome. This is a repeatedly measured continuous variable. The absolute internal diameter of the middle segment of RCA were and will be collected at six time points of illness: enrollment, 2th week (±2 days), 1th month (+5 days), 3th month (±5 days), 6th month (±5 days) and 12th month (±5 days), respectively. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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