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Table 2 Visit schedule

From: TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial

  Study time points (months)
  0 0 ½ 3 6 9 12 15 18 21 24
Assessment Visit 1 Visit 2 Phone Call Visit 3 Visit 4 Phone Call Visit 5 Phone Call Visit 6 Phone Call Visit 7
Consent x           
Enrolment/randomisation   x          
CT angiography x       xa     x
Ultrasound x     x   x   x   x
Blood test (safety) x    x    x     x
Blood collection (study) x     x   x   x   x
Resting brachial BP x    x x   x   x   x
SF-36 questionnaire x       x     x
Physical assessments x±    x x   x   x   x
Medical examination x    x    x     x
Resting ABI x       x     x
Collection of study medication   x    x   x   x   
Return of study medication      x   x   x   x
Event outcomes     x x   x   x   x
AE and compliance check    x x x x x x x x x
  1. Physical assessments include: resting BP, resting heart rate, weight, hip and waist measurements, ±indicates an additional assessment of height. ABI, ankle brachial-index; AE, adverse effects; BP, blood pressure; CT, computed tomography
  2. aThe Leiden and Stanford study centres will not perform 12-month CTAs due to local ethics regulations. The Stanford centre will utilize a slightly different study schedule. In place of the 2-week phone call and 3-month visit, participants will attend for a safety visit at 1 month for assessment of adherence to study treatment and medication side effects. Study medications will be prescribed at 3-month intervals with AE and compliance checks at 3, 9, 15 and 21 months