Table 3.
Visit | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
---|---|---|---|---|---|---|---|
Status | Screening | Baseline | Follow-up phase | ||||
Week | −4 ~ 0 | 0 | 1 (±3 day) | 4 (±7 day) | 8 (±7 day) | 12 (±7 day) | 16 |
Informed consent | ● | ||||||
Inclusion/exclusion criteria | ● | ||||||
Baseline characteristics | ● | ||||||
Risk factors | ● | ||||||
Medical history | ● | ||||||
Past medication history1 | ● | ||||||
Family history | ● | ||||||
Randomization | ● | ||||||
Physical examination | ● | ● | |||||
Vital signs | ● | ● | ● | ● | ● | ||
Height/weight2 | ● | ● | ● | ● | ● | ||
Blood analysis3 | ● | ● | |||||
Pregnancy test4 | ● | ● | |||||
ECG | ● | ● | |||||
Echocardiography | ● | ● | |||||
Exercise test | ● | ● | |||||
CMR5 | ● | ● | |||||
CAG or CCTA | ● | ||||||
SF-36 questionnaire | ● | ● | |||||
BISF-W self-assessment questionnaire | ● | ● | |||||
Case drug distribution | ● | ● | ● | ||||
Case drug collection | ● | ● | ● | ||||
Trial evaluation | |||||||
Adverse events | ● | ● | ● | ● | ● | ● | ● |
Patient’s compliance | ● | ● | ● | ● | |||
Concomitant medications6 | ● | ● | ● | ● | ● |
CMR; Cardiac magnetic resonance image, CAG; Coronary angiography, CCTA; Coronary CT angiography, ECG; Electrocardiogram.
1The participant’s usual medication regimen continued unchanged throughout study duration.
2Check weight only after Visit 2.
3CBC: WBC, Hemoglobin, Hematocrit, Platelet; Chemistry: Total protein, Albumin, Globulin, Total bilirubin, AST; aspartate aminotransferase, ALT; alanine transaminase, ALP; alkaline phosphatase, BUN; blood urea nitrogen, Creatinine, Uric acid; Electrolyte: Na, K, Cl; NT-proBNP; N-terminal of the prohormone brain natriuretic peptide; hs-CRP; high-sensitivity c-reactive protein.
(NT-proBNP, hs-CRP: check visit 1 and visit 5).
4Women of child-bearing age.
5Stop all medications three days before CMR.
6Concomitant medications: beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, statin, and trimetazidine.