Schedule of assessments for the strategy to obtain warfarin or direct oral anticoagulant’s benefit by evaluating registry study
Study period | ||||
Visit | V1 | V2 | V3 | V4 |
Timing (months, ±3) | 0* | 12 | 24 | 36 |
Baseline assessment | Follow-up | Follow-up complete/early termination | ||
Informed consent | ● | |||
Screening/eligibility | ● | |||
Basic information† | ● | |||
Annual examinations‡ | ● | ● | ● | ● |
Laboratory tests§ | ● | ○ | ○ | ● |
Physiological tests¶, brain MRI, GDS | ● | ○ | ○ | ● |
Other examinations** | ○ | ○ | ○ | ○ |
Brain scintigraphy (SPECT) | ○ | ○ | ○ | ○ |
Apolipoprotein E | ● | |||
Clinical outcomes/endpoints | ● | ● | ● |
●: required, ○: optional.
*Information obtained within 3 months before informed consent can be used at enrolment.
†Basic information includes: (1) demographics and vital signs, (2) risk factors, (3) medical history, (4) medications, and (5) social factors and lifestyles.
‡Annual examinations include vital signs and comprehensive geriatric assessment consisting of a fundamental activities of daily living (ADL) scale (Barthel Index), instrumental ADL scale (Lawton and Brody), the Mini-Mental State Examination, Montreal Cognitive Assessment and Clinical Dementia Rating scale.
§Laboratory tests include blood count, blood biochemistry, urinalysis and biomarkers such as high-sensitive C reactive protein, interleukin 6, N-terminal pro B-type natriuretic peptide, cardiac troponin T, and alpha-2-macroglobulin.
¶Physiological tests include arterial stiffness assessment and echocardiography.
**Other examinations include carotid echography, neurophysiological, physical, and nutritional assessments.
GDS, Geriatric Depression Scale; SPECT, Single photon emission CT.