Presurgery Screening Period Sample Clauses

Presurgery Screening Period. In the screening phase, potential subjects will be screened to determine eligibility for participation in the study. Documentation of screening failure details may be recorded using eligibility screening forms or a subject screening failure log. Within 60 days before surgery the subject must have a documented LVEF £25%. If more than one documented LVEF is available, the one closest to the surgery date should be used for screening purposes. At the screening visit and within 24 hours before surgery, an ECG and blood samples for CK and CK-MB and troponins, other routine laboratory tests should be obtained. All subjects will be asked at baseline to provide contact details and additional information when permitted by local regulations, such as name, address, phone numbers, employer (name, address, phone numbers), e-mail address, social security number or equivalent, health insurance provider, health insurance policy number; relatives (name, relationship, address, phone numbers), other contacts who have personal knowledge of the subject (e.g., friends or neighbors), primary care physician, other health care provider (cardiologist, dentist, etc.), to ensure Day 30 and Day 90 follow-up. A reliable contact must be made at Day 30 and Day 90 preferably by speaking directly to the subject or to someone who has knowledge of the subject's vital status or by a documented source containing all of the required study relevant information (e.g., dialysis center records, laboratory reports, medical visit records).