Table 1.
Sample-Size Estimation for Future RCTs Investigating Therapy for Reducing MI Size by CMR
| Patient Inclusion Criteria |
Pooled MI Size by CMR in the Control Group From Previous RCTs (as %LV) |
Sample Size per Group After Accounting for Potential Dropouts (9% for Acute CMR and 13% for Follow-Up CMR) for 90% Power With a 2-Sided Alpha of 0.05 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| For an Effect Size of 20% |
For an Effect Size of 25% |
For an Effect Size of 30% |
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| TIMI Flow Pre-PPCI | Symptom Onset (h) | Weighted Mean (95% CI) | SD | Number of Studies (Number of Patients) | MI Size | Sample Size | MI Size | Sample Size | MI Size | Sample Size |
| Acute scan only (including STEMI in all coronary territories) | ||||||||||
| 0 or 1 | ≤6 | 22 (20–24) | 12 | 3 RCTs (136 patients): Chan (2012) Garcia-Dorado (2014) Waltenberg (2014) |
17.6 | 171 | 16.5 | 110 | 15.4 | 76 |
| 0 or 1 | ≤12 | 24 (22–26) | 13 | 3 RCTs (189 patients): Freixa (2011) Mewton (2013) Siddiqi (2014) White (2015) |
19.2 | 169 | 18.0 | 108 | 16.8 | 75 |
| 0–3 | ≤12 | 21 (19–22) | 14 | 5 RCTs (305 patients): Yoon (2013) Ko (2014) Hoole (2015) McCann (2015) Liu (2016) |
16.8 | 265 | 15.8 | 164 | 14.7 | 85 |
| Chronic scan only (including STEMI in all coronary territories) | ||||||||||
| 0 or 1 | ≤6 | 15 (14–17) | 9 | 4 RCTs (152 patients): Tarantini (2012) Atar (2015) Waltenberg (2014) Roos (2016) |
12.0 | 215 | 11.3 | 215 | 10.5 | 96 |
| 0 or 1 | ≤12 | 15 (13–16) | 9 | 4 RCTs (186 patients): Lonborg (2010) Freixa (2011) Lonborg (2012) Siddiqi (2014) |
12.0 | 215 | 11.3 | 216 | 10.5 | 96 |
| 0–3 | ≤12 | 15 (14–17) | 11 | 4 RCTs (284 patients): Song (2009) Ranchord (2012) Roolvink (2016) Ko (2014) |
12.0 | 320 | 11.3 | 205 | 10.5 | 142 |
The references for the RCTs included in each row are provided in Online Table 5.
CI = confidence interval; CMR = cardiac magnetic resonance; MI = myocardial infarction; %LV = percentage of left ventricular mass or volume; PPCI = primary percutaneous coronary intervention; RCT = randomized controlled trial; TIMI = Thrombolysis in Myocardial Infarction.