Table 3.
Frequency and scope of the JenaMACS study visits.
| Time Point | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Protocol Item | Pre PCI | Post-PCI | Day 1 | Day 2 | Day 3-X * | Stabilization + | Day 7/E | 30 Rays | 6 M. | 12 M. |
| Inclusion/exclusion criteria | X | |||||||||
| Informed consent | X | |||||||||
| 12-lead surface ECG | X | X | X | X | X | X | X | X | ||
| Laboratory evaluation ∆ | X | X | X | X | X | X | ||||
| Medical history, Comorbidities ∆ | X | |||||||||
| Physical examination ∆ | X | X | X | X | X | X | X | X | X | X |
| BGA including lactate | X | X | X | X | X | X | ||||
| Creatinine clearance ** | X | X | X | X | ||||||
| Blood Samples (Measurement of biomarkers) | X | X | X | X | X | X | X | X | X | X |
| PAC—Hemodynamics | X | X | X | X | X | X | ||||
| Measurement of parameters of hemodynamics ∆ | X | X | X | X | X | X | ||||
| TTE | X | X | X | X | X | X | X | X | ||
| Dose of isotopes and vasopressors | X | X | X | X | X | X | X | X | ||
| Impella CP® data | X | X | X | X | X | X | ||||
| SAPS-II Score | X | X | X | X | X | |||||
| CCS category | X | X | X | |||||||
| NYHA category | X | X | X | |||||||
| Quality of Life (EQ-5D) | X | X | X | X | ||||||
| Measurement of the neurological outcome (GCS) ∆ | X | X | X | X | X | X | X | X | X | X |
∆ Data documentation from clinical routine (if available), * every day until hemodynamic stabilization; ** Clearance calculated according to Cockcroft-Gault formula; + after Impella explantation; SAPS = Simplified Acute Physiology Score; ECG = Electrocardiography; TTE = Transthoracic echocardiogram; PAC = Pulmonary artery catheterization; NYHA = New York Heart Association; CCS = Canadian Cardiovascular Society; GCS = Glasgow coma scale; PCI = Percutaneous, coronary intervention; BGA = Blood gas analyses. EQ—5D = EuroQol questionnaire.