Table 1.
PRE-MACE protocol data collection
| Testing and data collection | Frequency over 90-day period |
|---|---|
| Remote monitoring | |
| Fitbit Charge 2 | Continuous |
| KardiaMobile AliveCor | Weekly |
| MACE intermediate biomarkers | |
| u-hs-cTnI | Day 0 (Baseline), Day 90 (Exit) |
| NT-proBNP | Baseline, Exit |
| hsCRP | Baseline, Exit |
| Mitra microsampling device (Apolipoprotein panel: A-I, A-II, A-IV, B, C-I, C-II, C-III, E, J) | Baseline, Day 30, Day 60, Exit with subset Day 90 and 120 |
| Proteomics discovery | Baseline |
| Patient reported outcomes | |
| PROMIS questionnaire | Baseline, Weekly |
| Depression | Baseline, Weekly |
| Emotional distress/anxiety | Baseline, Weekly |
| Fatigue | Baseline, Weekly |
| Physical function | Baseline, Weekly |
| Sleep disturbance | Baseline, Weekly |
| Social isolation | Baseline, Weekly |
| Global mental health | Baseline, Weekly |
| Global physical health | Baseline, Weekly |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, Bimonthly |
| Seattle Angina Questionnaire (SAQ) | Baseline, Monthly |