Study population and design Sample Clauses

Study population and design. We studied 259 patients included in the Glycometabolic Intervention as adjunct to Primary percutaneous intervention in ST elevation myocardial infarction (GIPS-III) trial with available CMR and 2D TTE assessments at four months after hospitalization for STEMI. This study is a subanalysis of the GIPS-III trial, a single-center, randomized, placebo-controlled trial, recruiting 380 consecutive patients presenting with a first STEMI between January 1, 2011 and May 26, 2013. Details on the GIPS-III trial have been reported previously [8,9]. In brief, 380 patients were randomized to take either 500 mg metformin or placebo twice daily during a period of four months. Written informed consent was obtained in all participants. One patient withdrew informed consent, leaving 379 patients in the final study. Major exclusion criteria were known diabetes mellitus (as patients with diabetes mellitus already received metformin and could therefore not be randomized), previous myocardial infarction, contraindications for CMR, the need for coronary artery bypass graft surgery, and severe renal dysfunction. The sample size of the study was determined for the primary efficacy measure, which was LVEF as measured by CMR at four months after the index event. Because no significant effect of metformin on LVEF was observed, and elaborate data collection including echocardiograms were obtained in most patients, the study was deemed suitable for further imaging substudies.
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Study population and design. As stated previously, the dataset was collected from a group of patients at the ADCs who were given a multitude of different tests including the MOCA and the MMSE. The dataset consists of both new and returning patients. Ideally, the study would have only consisted of new patients; however, due to time constraints, both tests were given to both new and returning patients.3 For this analysis we are only interested in the study visits during which the Crosswalk study was completed for the first time. If the returning patients have more than one visit, the extra visits will be ignored. Patient recruitment was stratified to ensure the majority of patients were either MCI or mildly demented, with ADCs being instructed to recruit the majority of patients with MMSE scores between 16 and 26 points. No scores below 10 points were included due to the difficulty of administering the tests at that severity of cognitive impairment.3 Each patient received the tests in a random order to ensure no learning effect was present. The authors found that this randomization was successful. More details can be found in Xxxxxxx et al. Statistical Analyses:

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