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Table 1 Schedule of enrollment, interventions, assessments, and outcome/safety measures for the octogenarian study

From: Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial

 

STUDY PERIOD

Enrollment

allocation

Post-allocation

Close-out

Time point**

 

0

day 1

in-hospital

at discharge

day 30

1 year

Enrollment:

       

Eligibility screen

X

      

Informed consent

X

      

History and ECG

X

      

Allocation

 

X

     

Interventions:

       

Medical treatment*

  

X

    

Invasive treatment strategy

   

X

   

Assessments:

       

Echocardiography and frailty score

X

      

QoL and angina questionnaire

X

     

X

Adverse events

   

X

X

X

X

If symptoms, additional assessments**

    

X

X

X

Outcome:

       

MACCE***

     

X

X§

Myocardial infarction

      

X

All-cause mortality

      

X

Safety measure: bleeding

   

X

X

X

X

  1. *Medical treatment will be given to all study participants regardless of treatment allocation, provided that there are no contraindications.
  2. **If symptoms of ischemia: ECG, CK-MB, and cardiac troponins. If symptoms of bleeding: hemoglobin and platelet count.
  3. *** Combined endpoint: MACCE: major adverse cardiac or cerebral event.
  4. §Primary endpoint of the study.
  5. QoL: Quality of life, ECG: Electrocardiogram.