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Table 3 Trial process chart

From: Understanding of chest pain in microvascular disease proved by cardiac magnetic resonance image (UMPIRE): study protocol for a randomized controlled trial

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

 

 
  1. CMR; Cardiac magnetic resonance image, CAG; Coronary angiography, CCTA; Coronary CT angiography, ECG; Electrocardiogram.
  2. 1The participant’s usual medication regimen continued unchanged throughout study duration.
  3. 2Check weight only after Visit 2.
  4. 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.
  5. (NT-proBNP, hs-CRP: check visit 1 and visit 5).
  6. 4Women of child-bearing age.
  7. 5Stop all medications three days before CMR.
  8. 6Concomitant medications: beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, statin, and trimetazidine.