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

Trials

Volumn 16, Issue 1, 2015, Pages

  Jabbar, Avais ^a   Ingoe, Lorna ^b   Pearce, Simon ^a,c   Zaman, Azfar ^a,c   Razvi, Salman ^a,b,d  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b GATESHEAD HEALTH NHS FOUNDATION TRUST   (United Kingdom)

^c NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^d NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

LEVOTHYROXINE; PLACEBO; THYROTROPIN; THYROXINE; BIOLOGICAL MARKER;

ACUTE HEART INFARCTION; ALGORITHM; ARTICLE; BLOOD CLOTTING; BLOOD RHEOLOGY; CONFIDENTIALITY; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; ENDOTHELIAL DYSFUNCTION; HEALTH STATUS; HEART LEFT VENTRICLE ENDDIASTOLIC VOLUME; HEART LEFT VENTRICLE FUNCTION; HOSPITAL ADMISSION; HUMAN; LONGITUDINAL STUDY; MEDICATION COMPLIANCE; NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; OBSERVATIONAL STUDY; PLATELET REACTIVITY; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; SUBCLINICAL HYPOTHYROIDISM; THROMBUS; THYROID FUNCTION; THYROID FUNCTION TEST; THYROTROPIN BLOOD LEVEL; TREATMENT DURATION; ASYMPTOMATIC DISEASE; BLOOD; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPLICATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ENGLAND; FEMALE; HYPOTHYROIDISM; MALE; METHODOLOGY; MULTICENTER STUDY; MYOCARDIAL INFARCTION; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; TIME FACTOR; TREATMENT OUTCOME;

ASYMPTOMATIC DISEASES; BIOMARKERS; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; ENGLAND; FEMALE; HUMANS; HYPOTHYROIDISM; LONGITUDINAL STUDIES; MALE; MYOCARDIAL INFARCTION; PROSPECTIVE STUDIES; RESEARCH DESIGN; THYROID FUNCTION TESTS; THYROTROPIN; THYROXINE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84925870538     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0621-5     Document Type: Article

References (38)

1. Luengo-Fernandez R, Leal J, Gray A, Petersen S, Rayner M. Cost of cardiovascular diseases in the United Kingdom. Heart. 2006;92:1384-9.
2. Klein I, Ojamaa K. Thyroid hormone and the cardiovascular system. N Engl J Med. 2001;344:501-9.
3. Hak AE, Pols HA, Visser TJ, Drexhage HA, Hofman A, Witteman JC. Subclinical hypothyroidism is an independent risk factor for atherosclerosis and myocardial infarction in elderly women: the Rotterdam Study. Ann Intern Med. 2000;132:270-8.
4. Walsh JP, Bremner AP, Bulsara MK, O'Leary P, Leedman PJ, Feddema P, et al. Subclinical thyroid dysfunction as a risk factor for cardiovascular disease. Arch Intern Med. 2005;165:2467-72.
5. Razvi S, Weaver JU, Vanderpump MP, Pearce SH. The incidence of ischemic heart disease and mortality in people with subclinical hypothyroidism: reanalysis of the Whickham Survey cohort. J Clin Endocrinol Metab. 2010;95:1734-40.
6. Parle JV, Maisonneuve P, Sheppard MC, Boyle P, Franklyn JA. Prediction of all-cause and cardiovascular mortality in elderly people from one low serum thyrotropin result: a 10-year cohort study. Lancet. 2001;358:861-5.
7. Cappola AR, Fried LP, Arnold AM, Danese MD, Kuller LH, Burke GL, et al. Thyroid status, cardiovascular risk, and mortality in older adults. Jama. 2006;295:1033-41.
8. Biondi B, Cooper DS. The clinical significance of subclinical thyroid dysfunction. Endocr Rev. 2008;29:76-131.
9. Iervasi G, Molinaro S, Landi P, Taddei MC, Galli E, Mariani F, et al. Association between increased mortality and mild thyroid dysfunction in cardiac patients. Arch Intern Med. 2007;167:1526-32.
10. Molinaro S, Iervasi G, Lorenzoni V, Coceani M, Landi P, Srebot V, et al. Persistence of mortality risk in patients with acute cardiac diseases and mild thyroid dysfunction. Am J Med Sci. 2012;343:65-70.
11. Pantos C, Mourouzis I, Galanopoulos G, Gavra M, Perimenis P, Spanou D, et al. Thyroid hormone receptor alpha1 downregulation in postischemic heart failure progression: the potential role of tissue hypothyroidism. Horm Metab Res. 2010;42:718-24.
12. Pingitore A, Chen Y, Gerdes AM, Iervasi G. Acute myocardial infarction and thyroid function: new pathophysiological and therapeutic perspectives. Ann Med. 2012;44:745-57.
13. Pantos C, Mourouzis I, Cokkinos DV. New insights into the role of thyroid hormone in cardiac remodeling: time to reconsider? Heart Fail Rev. 2011;16:79-96.
14. Rodondi N, Bauer DC, Cappola AR, Cornuz J, Robbins J, Fried LP, et al. Subclinical thyroid dysfunction, cardiac function, and the risk of heart failure. The Cardiovascular Health study. J Am Coll Cardiol. 2008;52:1152-9.
15. Biondi B, Fazio S, Palmieri EA, Carella C, Panza N, Cittadini A, et al. Left ventricular diastolic dysfunction in patients with subclinical hypothyroidism. J Clin Endocrinol Metab. 1999;84:2064-7.
16. Monzani F, Di Bello V, Caraccio N, Bertini A, Giorgi D, Giusti C, et al. Effect of levothyroxine on cardiac function and structure in subclinical hypothyroidism: a double blind, placebo-controlled study. J Clin Endocrinol Metab. 2001;86:1110-5.
17. Ripoli A, Pingitore A, Favilli B, Bottoni A, Turchi S, Osman NF, et al. Does subclinical hypothyroidism affect cardiac pump performance? Evidence from a magnetic resonance imaging study. J Am Coll Cardiol. 2005;45:439-45.
18. Viswanathan G, Balasubramaniam K, Hardy R, Marshall S, Zaman A, Razvi S. Blood thrombogenicity is independently associated with serum TSH levels in post-non-ST elevation acute coronary syndrome. J Clin Endocrinol Metab. 2014;99:E1050-4.
19. Pohost GM, Hung L, Doyle M. Clinical use of cardiovascular magnetic resonance. Circulation. 2003;108:647-53.
20. Chang SA, Chang HJ, Choi SI, Chun EJ, Yoon YE, Kim HK, et al. Usefulness of left ventricular dyssynchrony after acute myocardial infarction, assessed by a tagging magnetic resonance image derived metric, as a determinant of ventricular remodeling. Am J Cardiol. 2009;104:19-23.
21. Lucking AJ, Chelliah R, Trotman AD, Connolly TM, Feuerstein GZ, Fox KA, et al. Characterisation and reproducibility of a human ex vivo model of thrombosis. Thromb Res. 2010;126:431-5.
22. Feuring M, Wehling M, Burkhardt H, Schultz A. Coagulation status in coronary artery disease patients with type II diabetes mellitus compared with non-diabetic coronary artery disease patients using the PFA-100(R) and ROTEM(R). Platelets. 2010;21:616-22.
23. Barua RS, Sy F, Srikanth S, Huang G, Javed U, Buhari C, et al. Acute cigarette smoke exposure reduces clot lysis-association between altered fibrin architecture and the response to t-PA. Thromb Res. 2010;126:426-30.
24. Vita JA, Holbrook M, Palmisano J, Shenouda SM, Chung WB, Hamburg NM, et al. Flow-induced arterial remodeling relates to endothelial function in the human forearm. Circulation. 2008;117:3126-33.
25. Bonetti PO, Pumper GM, Higano ST, Holmes Jr DR, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004;44:2137-41.
26. Matsuzawa Y, Sugiyama S, Sugamura K, Nozaki T, Ohba K, Konishi M, et al. Digital assessment of endothelial function and ischemic heart disease in women. J Am Coll Cardiol. 2010;55:1688-96.
27. Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, et al. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008;117:2467-74.
28. Rubinshtein R, Kuvin JT, Soffler M, Lennon RJ, Lavi S, Nelson RE, et al. Assessment of endothelial function by non-invasive peripheral arterial tonometry predicts late cardiovascular adverse events. Eur Heart J. 2010;31:1142-8.
29. EMC Mercury Pharmaceuticals. http://www.medicines.org.uk/emc/medicine/27213 . Accessed 08 Nov 2014.
30. EMC Mercury Pharmaceuticals. http://www.medicines.org.uk/emc/medicine/22557 . Accessed 08 Nov 2014
31. Doughty RN, Whalley GA, Walsh HA, Gamble GD, Lopez-Sendon J, Sharpe N, et al. Effects of carvedilol on left ventricular remodeling after acute myocardial infarction: the CAPRICORN Echo Substudy. Circulation. 2004;109:201-6.
32. Sharpe N, Smith H, Murphy J, Greaves S, Hart H, Gamble G. Early prevention of left ventricular dysfunction after myocardial infarction with angiotensin-converting-enzyme inhibition. Lancet. 1991;337:872-6.
33. Frison L, Pocock SJ. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med. 1992;11:1685-704.
34. Sierra-Galan LM, Ingkanisorn WP, Rhoads KL, Agyeman KO, Arai AE. Qualitative assessment of regional left ventricular function can predict MRI or radionuclide ejection fraction: an objective alternative to eyeball estimates. J Cardiovasc Magn Reson. 2003;5:451-63.
35. Medicines for Human use in Clinical Trials. http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm . Accessed 10 Nov 2014
36. Kitakaze M. How to mediate cardioprotection in ischemic hearts-accumulated evidence of basic research should translate to clinical medicine. Cardiovasc Drugs Ther/Sponsored Int Soc Cardiovasc Pharmacother. 2010;24:217-23.
37. Nicolini G, Pitto L, Kusmic C, Balzan S, Sabatino L, Iervasi G, et al. New insights into mechanisms of cardioprotection mediated by thyroid hormones. J Thyroid Res. 2013;2013:264387. doi:10.1155/2013/264387.
38. Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160(4):526-34.