Table 2.
Schedule of Procedures in TIME (Day 0 is the day of revascularization)
| Day 1 or 2 (Consent) |
Day 3/7 (SPI) |
Day 4/8 |
Month 1 |
Month 3 |
Month 6 |
Month 12 |
Month 24 |
|
|---|---|---|---|---|---|---|---|---|
| Complete medical hx | X | |||||||
| Incremental medical hx | X | X | X | X | X | X | X | |
| Informed consent | X | |||||||
| Physical exam | X | X | X | X | X | X | X | X |
| Laboratory tests | X | X | X | X | X | X | X | X |
| Pregnancy Test* | X | X | X | X | X | X | ||
| ECHO | X | X | ||||||
| EKG | X | X | X | X | ||||
| Bone marrow aspiration | X | |||||||
| Biorepository blood draws | X | X | X | |||||
| Cardiac MRI | X | X | X | X | ||||
| Study product infusion (SPI) | X | |||||||
| Medication review | X | X | X | X | X | X | X | X |
| AE/SAE evaluations | X | X | X | X | X | X | X | |
| Telemetry (18–24 hrs post SPI) | X | |||||||
| Holter | X |
*
In women of childbearing age