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Table 1 Schedule of events for ThyrAMI 2

From: Thyroxine in acute myocardial infarction (ThyrAMI) - levothyroxine in subclinical hypothyroidism post-acute myocardial infarction: study protocol for a randomised controlled trial

  Pre-screening Baseline Randomisation follow-up
VISIT   1A 1B 1C   2 3 4 5 6A 6B 6C 7
assessments Within 24 hours of AMI 7 to 10 days post AMI Day 0   Week 4 (+/− 7 days) Week 8 (+/− 7 days) Week 12 (+/− 7 days) Week 24 (+/− 7 days) Week 52 (+/− 7 days) Week 53 (+/− 7 days)
Identification and initial approach (including provision of PIS) X             
Eligibility criteria checked X             
Written informed consentǂ   X            
Physical examination (height ****, weight, BP, pulse)   X           X  
Venepuncture   X*     X** X** X** X**    X*  
Clinical history (medical history, medication list)   X            
Questionnaires (SF12, MLWHFQ, CES-D) completed   X           X  
Safety checks (ECG, pulse oximetry and NYHA assessment   X     X X X X    X  
Cardiac MRI    X        X    
EndoPat, Badimon chamber, VerifyNow and TEG analysis     X        X   
Randomisation (after written informed consent obtained) and study drug dispensation      X #         
Study medication prescribed and dispensed (following LT4 dose assessment at visits 2 to 5 only)       X X X X     
Study medication compliance checks       X X X X    X  
Concomitant medication       X X X X    X  
Adverse events       X X X X    X X
Serious adverse events       X X X X    X X
  1. X* 20 ml blood: TSH, FT4, FT3, TPO antibodies, Total cholesterol, HDL, Triglycerides, serum BNP, endothelial markers (10 ml gel/gold tube and 10 ml EDTA/purple tube).
  2. X** 5 ml blood: TSH, FT4, FT3 only (gel/gold tube).
  3. Height ****: To be measured at baseline visit only (or could be self-reported if apparatus not available; for example at participant’s home).
  4. ǂ After full discussion and answering any questions.
  5. List of Abbreviations:
  6. BP, blood pressure; BTF, British Thyroid Foundation; CES-D, Centre for Epidemiologic Studies Depression Scale; ECG, electrocardiogram; LT4, levothyroxine; MLWHFQ, Minnesota Living With Heart Failure Questionnaire; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PIS, patient information sheet(s); SF12, short-form health survey; TEG, thromboelastography.