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. 2014 Aug 26;15:333. doi: 10.1186/1745-6215-15-333

Table 3.

Trial process chart

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.