ThyrAMI: Multi-centre double-blinded placebo-controlled RCT (cTIMP) of sub-clinical hypothyroid individuals post acute myocardial infarction

Gateshead Health NHS Foundation Trust0 个研究点目标入组 95 人开始时间: 2015年1月9日最近更新: 2020年8月3日

试验速览

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25872532 2. 2017 results presented at Society for Endocrinology BES 2017: DOI: 10.1530/endoabs.50.P386 3. 2020 results in https://pubmed.ncbi.nlm.nih.gov/32692386/ (added 22/07/2020)

•1. Males and females aged between 18-75 yrs
•2. Serum TSH between 4.01 -10.00 mU/L with normal free thyroxine levels (9 – 25 pmol/L) on two occasions (on day of admission for AMI and 7-10 days after AMI)
•3. Acute myocardial infarction diagnosed on admission to hospital (chest pain with dynamic ECG changes or increase troponin enzymes (at least a fourfold increase above normal range)

•1. Patients on medications affecting thyroid function (levothyroxine, carbimazole, propylthiouracil, amiodarone, lithium)
•2. Patients who are unable to provide written informed consent
•3. Patients with advanced malignancy (who, in the opinion of the investigator, is unlikely to survive for more than 6 months)
•4. Patients with sustained ventricular tachycardia requiring treatment which occurs >24hrs after myocardial re-perfusion/revascularisation
•5. Patients who have contra-indications to MR scanning (cardiac pacemaker, metallic heart valves, cochlear implants, coronary artery stents incompatible with MR scanning, etc.)
•6. Patients who are unlikely or unwilling, in the opinion of the investigator, to attend for study specific visits
•7. Participants whose serum TSH is >10.0 or <4.0 on either occasion
•8. Patients who are already participating in another interventional study

发起方