Table 2.
Pre-specified primary and secondary outcome measures
| Measure | Nitrite | Placebo | Effect size (95% CI); P-value |
|---|---|---|---|
| Primary outcome | |||
| Infarct size at 6–8 days | n = 85 | n = 88 | |
| Mean (SD) | 22.9 (13.5) | 23.1 (13.2) | −0.7 (−2.2, 0.7); 0.30 |
| Median (25th, 75th) | 22 (12, 33) | 20 (13, 32) | |
| Area at risk | |||
| Mean (SD) | 33.1 (15.8) | 32.4 (14.1) | |
| Median (25th, 75th) | 31 (21, 44) | 32.5 (22.5, 42) | |
| Secondary outcomes | |||
| Troponin AUC | n = 81 | n = 87 | |
| Mean (SD) | 3734 (3091) | 3807 (3262) | −125 (−1139, 888); 0.81 |
| CK AUC | n = 81 | n = 87 | |
| Mean (SD) | 67 019 (42 446) | 59 574 (48 337) | 5766 (−8695, 20 288); 0.79 |
| Infarct size 6–8 days (5-SD) | n = 82 | n = 84 | |
| Mean (SD) | 14.5 (10.5) | 14.7 (11.2) | 0.1 (−2.5, 2.8); 0.92 |
| Median (25th, 75th) | 12 (6, 20) | 11.5 (7, 22) | |
| Area at risk (T2) | n = 39 | n = 46 | |
| Mean (SD) | 36.1 (24.8) | 38.1 (16.9) | |
| Median (25th, 75th) | 33 (19, 46) | 39 (26 ,51) | |
| Final infarct size at 6 months | n = 63 | n = 55 | −1.7 (−3.2, 5.5); 0.19 |
| Mean (SD) | 13.3 (8.7) | 15.0 (9.7) | |
| Median (25th, 75th) | 12 (7, 17) | 14 (8, 20) | |
| LVEDV (mL) at 6–8 days | n = 75 | n = 84 | −3.5 (−16.3, 9.2); 0.58 |
| Mean (SD) | 159 (41) | 162 (40) | |
| LVEDV (mL) at 6 months | n = 64 | n = 54 | |
| Mean (SD) | 159 (42) | 165 (37) | −5.0 (−19.8, 9.8); 0.50 |
| LVEDV (mL) (delta) | n = 63 | n = 51 | |
| Mean (SD) | −1 (29) | −3 (32) | 1.3 (−10.1, 12.6); 0.82 |
| LVESV (mL) at 6–8 days | n = 75 | n = 84 | |
| Mean (SD) | 85 (36) | 85 (32) | 0.5 (−10.4,11.3); 0.93 |
| LVESV (mL) at 6 months | n = 64 | n = 54 | |
| Mean (SD) | 75 (31) | 78 (28) | −2.7 (−13.7,8.3); 0.63 |
| LVDV mL (delta) | n = 63 | n = 63 | |
| Mean (SD) | 9 (25) | 6 (24) | 2.0 (−7.2, 11.2); 0.66 |
| LVEF % at 6–8 days | n = 75 | n = 84 | |
| Mean (SD) | 48 (11) | 50 (18) | −2.3 (−7.1, 2.4); 0.34 |
| LVEF % at 6 months | n = 64 | n = 54 | |
| Mean (SD) | 53 (9) | 53 (9) | −0.6 (−3.9, 2.7); 0.72 |
| LVEF % (delta) | n = 63 | n = 51 | |
| Mean (SD) | −5 (8) | −3 (22) | −1.7 (−7.6, 4.2); 0.57 |
Pre-specified primary and secondary outcome measures. LVEDV, LV, end-diastolic volume; LVESV, LV end-systolic volume; LVEF, LV ejection fraction; Delta, Change between first and second scan.