Sample Size in Clinical Cardioprotection Trials Using Myocardial Salvage Index, Infarct Size, or Biochemical Markers as Endpoint
Why the study?
Does using myocardial salvage index (MSI) by CMR reduce the required sample size in cardioprotection trials compared to MI size alone or biochemical markers?
Population
90 control patients from the CHILL-MI and MITOCARE trials (50 from CHILL-MI with hsTnT and CKMB data)
Comparison
Myocardial salvage index assessed by cardiac… vs Myocardial infarct size alone or biochemical…
Design
Other
Authors
Discussion
Loading...
Member takes
Implication
MSI by CMR may enable smaller cardioprotection trials; leaves open prospective validation of efficiency gains.
Structured PICO
Does using myocardial salvage index (MSI) by CMR reduce the required sample size in cardioprotection trials compared to MI size alone or biochemical markers?
P
Population
90 control patients from the CHILL-MI and MITOCARE trials (50 from CHILL-MI with hsTnT and CKMB data)
I
Intervention
Myocardial salvage index (MSI) assessed by cardiac magnetic resonance (CMR) as a trial endpoint
C
Comparator
Myocardial infarct (MI) size alone or biochemical markers (hsTnT, CKMB) as trial endpoints
O
Outcome
Sample size required to reach 90% statistical power for a 25% decrease in outcome variablessurrogate
Using myocardial salvage index by CMR as an endpoint in cardioprotection trials can reduce required sample sizes by 46% to 65% compared to MI size alone or biochemical markers.
Cite This Study
Engblom et al. (2016) studied this question.