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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