Table 1.
Schedule of enrollment, interventions, assessments, and outcome/safety measures for the octogenarian study
| 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 | |||
*Medical treatment will be given to all study participants regardless of treatment allocation, provided that there are no contraindications.
**If symptoms of ischemia: ECG, CK-MB, and cardiac troponins. If symptoms of bleeding: hemoglobin and platelet count.
***Combined endpoint: MACCE: major adverse cardiac or cerebral event.
§Primary endpoint of the study.
QoL: Quality of life, ECG: Electrocardiogram.