THYRoxine in Acute Myocardial Infarction (ThyrAMI)
Research type
Research Study
Full title
THYRoxine in Acute Myocardial Infarction (ThyrAMI)
IRAS ID
151865
Contact name
Salman Razvi
Contact email
Sponsor organisation
Gateshead Health NHS Foundation Trust
Eudract number
2014-001369-28
Research summary
Changes in thyroid hormone concentration, even if small, have been shown to adversely affect the heart and blood vessels. For example, mild underactive (hypo)and overactive (hyper)thyroid have been associated with a 20-80% increase in cardiac problems. Much research on heart disease has focused on men, as these diseases occur at younger ages and are more severe in males. Risk factors for heart disease in women are relatively less well understood. Thyroid disease is predominantly a disease of women and is increasingly being recognised as an adverse risk factor for heart disease.
Research has suggested that the use of Levothyroxine may help reduce the heart disease risk from hypothyroidism, and additionally improve the outcomes of acute myocardial infarction (heart attack).
Levothyroxine is already in widespread use, being prescribed to around 3% of the UK population. A long-term study has shown participants with mild hypothyroidism treated with Levothyroxine had a 72% reduction in heart failure events.
The current study will aim to asses two aspects in relation to the above:
ThyrAMI-1 is an observational study that will last for 24 months. The aim is to assess the proportion of patients with a new heart attack who have thyroid hormone abnormalities, and whether thyroid function at the time of the new heart attack is related to poorer outcomes. The study will focus on males and females 18 years or over diagnosed with a new heart attack (within 24 hours).
ThyrAMI-2 is an additional study to assess whether treatment of mild hypothyroidism with Levothyroxine following a new heart attack leads to improved heart muscle function and also improves blood vessel function, clot size and quality of life. This study will focus on males and females aged 18–75 years who were diagnosed with a new heart attack on hospital admission, and whose blood hormones meet certain criteria.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0151
Date of REC Opinion
28 May 2014
REC opinion
Favourable Opinion