Table 1.

Primary and Secondary Cardiac Outcomes

Primary Outcomes

1. Worst-ever LVEF

2. Worst-ever maximum z-score of the proximal LAD or RCA

Secondary Cardiac Outcomes

1. Occurrence of a proximal LAD or RCA z-score of ≥2.5 on any echocardiogram

2. Occurrence of aneurysms by Japanese Ministry of Health criteria

3. Individual z-scores for the LMCA, RCA, and LAD

4. Left ventricular size and function: LVEDV z-score, LVEF, LVSF

5. Percentage of patients who had LVEF <55% on any echocardiogram

a. LVEF 45–54% (mildly depressed systolic function)

b. LVEF 35–44% (moderately depressed systolic function)

c. LVEF <35% (severely depressed systolic function

6. LV strain

a. Global longitudinal strain from apical view

b. Global circumferential strain from parasternal short-axis view

7. Right ventricular systolic function (qualitative assessment)

a. If possible, right ventricular global longitudinal strain

8. Presence and degree of mitral and aortic valve insufficiency

9. LV diastolic function, i.e., tissue Doppler imaging and mitral valve inflow

10. Presence and size of pericardial effusion

11. The occurrence of arrhythmias and conduction system disturbances

12. Exercise testing (age and maturing permitting) at ~3 months in those who had at least moderate systolic dysfunction

13. CMR outcomes

a. LVEF and RVEF

b. Valvar regurgitation

c. Percent of participants with

i. Myocardial late gadolinium enhancement, and its distribution

ii. Abnormal LV T2-weighted imaging

iii. Elevated LV T2

iv. Elevated LV native T1

v. Elevated LV extracellular volume fraction

vi. Coronary artery dilation

vii. Final interpretation of CMR as abnormal, equivocal, or normal

LVEF=Left ventricular ejection fraction; LAD=Left anterior descending; RCA=Right coronary artery; LMCA=Left main coronary artery; LVEDV=Left ventricular end-diastolic volume; LVSF=Left ventricular shortening fraction; CMR=Cardiac magnetic resonance imaging; RVEF=Right ventricular ejection fraction