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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.