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Table 1 Schedule of the study, with all detailed assessments for each study period

From: Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF)

 

Study period

Enrollment

Allocation

Post-allocation

Close- out

Timepoint**

Interview

Rand

1 M

6 M

12 M

24 M

36 M

48 M

60 M

Enrollment

X

        

Eligibility screen

X

        

Informed consent

 

X

       

Allocation

 

X

       

Angiograms

 

X

       

History/events

X

X

X

X

X

X

X

X

X

Anginal assessment

X

X

X

X

X

X

X

X

X

Dyspnea assessment

X

X

X

X

X

X

X

X

X

Medicines

X

X

X

X

X

X

X

X

X

ECG

X

 

X

 

X

X

X

X

X

Echocardiography

X

 

X

     

X

Laboratory

X

   

X

X

X

X

X

Interventions:

 Surgery

  

X

      

 Angiograms

        

X

Assessments:

 Follow-up

  

X

X

X

X

X

X

X

 CT angiography

        

X

 Neuropsychological Tests

  

X

     

X

 ECG stress tests

    

X

   

X

 Quality of life

X

  

X

X

X

X

X

X

 Costs and effectiveness

  

X

     

X

 Working status

  

X

     

X

  1. M month, ECG electrocardiogram. Laboratory tests will include creatinine, LDL-cholesterol, glycated hemoglobin, CK-MB, troponin, and BNP levels
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Trials

ISSN: 1745-6215