Table 2 SPIRIT overview of study visits and procedures
Study Period | ||||||
|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||
Visit 1 | Visit 2 | V3 | V4 | V5 | Visit 6 | |
Timepoint | -1 month | 0 | 1 M | 3 M | 6 M | 12 month |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Biochemistry | X | X | X | X | X | |
Blood count | X | X | X | X | X | |
NT-pro BNP | X | X | X | X | X | |
CK-MB, troponin I | X | X | X | X | X | |
ECG | X | X | X | X | X | X |
Allocation | X | |||||
Interventions | ||||||
BMAC application | X | |||||
Standard HF therapy | X | |||||
Assessments | ||||||
MRI/ECHO | X | X | ||||
LVESd/LVEDd | X | X | ||||
LVESV/LVEDV | X | X | ||||
LV EF | X | X | ||||
TMS%; PI% | X | X | ||||
Corridor walk test | X | X | X | |||
24-h ECG Holter | X | X | ||||
Kanas City Cardiomyopathy Questionare | X | X | X | |||