Table 2.
Schedule of investigations | Baseline (pre-PCI) |
Procedure | Postprocedure/ discharge | 30 days (±7 days) |
3 months (±14 days) |
6 months (±14 days) |
12 months (±30 days) |
Visit or phone contact | Visit or phone contact | Visit or phone contact | Visit or phone contact |
||||
Inclusion/exclusion criteria | • | ||||||
Informed consent | • | ||||||
History and risk factors | • | ||||||
Physical examination | • | ||||||
Anginal status | • | • | • | • | • | • | |
Recording of medications | • | • | • | • | • | • | |
12-lead electrocardiography | •† | •‡ | |||||
Cardiac enzymes (CK–MB and troponin) | •§ | •¶ | |||||
Serious adverse events** | • | • | • | • | • | • | |
V-RESOLVE score calculation | • |
• Procedure need to be performed or data need to be collected.
†Electrocardiography (ECG) at time of screening should be performed within 72 hours prior to PCI procedure.
‡ECG within 24 hours postprocedure or at discharge, whichever comes first.
§Cardiac biomarkers per standard of care and local practice is drawn prior to the index PCI procedure (within 24 hours prior to PCI).
¶CK–MB and troponin in the postprocedure hospitalisation period should be taken approximately 3–6 hours postprocedure). If cardiac enzymes are elevated (according to local upper limit of normal), serial measurements of cardiac enzymes must be taken until a decline is noted.
**For all revascularisations (including stent thrombosis and so on), the angiogram must be sent to the monitor organisation.
Note: In the event of undercurrents illnesses, interventions, adverse events or treatment failure, effort should be made to complete the required observations as much as possible.
CK–MB, creatine kinase–myocardial band; PCI, percutaneous coronary interventions.