Visit | Screening | Visit 1 | Visit 2 (only patients 1–90) | Visit 3 | Visit 4 | Visit 5 | Follow-up |
---|---|---|---|---|---|---|---|
Trial day | 1 | 1 (randomisation) | 1 (2 h after first dose) | 1 (6–12 h after intervention) | 2 (1 day after intervention) | 7 (±2) | 28 (±3) |
Demographics (eg, sex, age, ethnicity) | X | ||||||
Patient information and informed consent | X | ||||||
Previous and concomitant diseases | X | X | |||||
Previous and concomitant treatments | X | X | |||||
Inclusion/exclusion criteria | X | ||||||
Physical examination | X | X | |||||
Vital signs (BP, pulse, temperature) | X | X | X | X | X | ||
Lab I (CK, troponin I, renal function) | X | X | |||||
Lab II (oxidative stress, inflammatory, platelet function) | X | X | X | X | X | ||
FMD | X | X | X | X | X | ||
L-FMC | X | X | X | X | X | ||
Reactive hyperaemia | X | X | X | X | X | ||
Randomisation | X | ||||||
Adverse events | X | X | X | X | X | ||
End of trial (final visit) | X |
BP, blood pressure; FMC, flow-mediated constriction; FMD, flow-mediated dilation.