Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)
NCT ID: NCT02512978
Last Updated: 2018-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2015-08-31
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)
NCT03096613
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
NCT04953195
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)
NCT03606824
Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
NCT02090907
Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
NCT02316743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Levothyroxine group
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Levothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Standard therapy group
The patients in this group receive standard therapy in consistent with the local clinical practice.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Levothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
3. With presence of hypothyroid status (i.e., TSH \>7.0 mIU/L and (or) fT3 \<1.79 pg/mL);
4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
Exclusion Criteria
2. Symptoms of severe heart failure (Killip Class III and above);
3. Severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl;
4. Impaired liver function before surgery: Serum GPT \> 120U/L;
5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
6. Those taking medicine which can affect the test of thyroid function;
7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
8. Those having prior myocardial infarction;
9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Municipal Science & Technology Commission
OTHER
Peking Union Medical College Hospital
OTHER
Peking University Third Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Beijing Friendship Hospital
OTHER
The Luhe Teaching Hospital of the Capital Medical University
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yi-Da Tang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yi-Da Tang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fuwai Cardiovascular Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23.
Pingitore A, Chen Y, Gerdes AM, Iervasi G. Acute myocardial infarction and thyroid function: new pathophysiological and therapeutic perspectives. Ann Med. 2012 Dec;44(8):745-57. doi: 10.3109/07853890.2011.573501. Epub 2011 May 13.
Mourouzis I, Forini F, Pantos C, Iervasi G. Thyroid hormone and cardiac disease: from basic concepts to clinical application. J Thyroid Res. 2011;2011:958626. doi: 10.4061/2011/958626. Epub 2011 Jun 19.
Cakar M, Demirbas S, Demirkol S, Karaman M, Balta S, Unlu M. Chicken or egg? Which one is first? Myocardial infarction or low thyroid hormones? Intern Med. 2013;52(5):645. doi: 10.2169/internalmedicine.52.9285. Epub 2013 Mar 1. No abstract available.
Ceremuzynski L, Gorecki A, Czerwosz L, Chamiec T, Bartoszewicz Z, Herbaczynska-Cedro K. Low serum triiodothyronine in acute myocardial infarction indicates major heart injury. Kardiol Pol. 2004 May;60(5):468-80; discussion 473-4. English, Polish.
Chen YF, Kobayashi S, Chen J, Redetzke RA, Said S, Liang Q, Gerdes AM. Short term triiodo-L-thyronine treatment inhibits cardiac myocyte apoptosis in border area after myocardial infarction in rats. J Mol Cell Cardiol. 2008 Jan;44(1):180-7. doi: 10.1016/j.yjmcc.2007.09.009. Epub 2007 Oct 26.
Bai MF, Gao CY, Yang CK, Wang XP, Liu J, Qi DT, Zhang Y, Hao PY, Li MW. Effects of thyroid dysfunction on the severity of coronary artery lesions and its prognosis. J Cardiol. 2014 Dec;64(6):496-500. doi: 10.1016/j.jjcc.2014.03.009. Epub 2014 Jun 17.
Wang WY, Tang YD, Yang M, Cui C, Mu M, Qian J, Yang YJ. Free triiodothyronine level indicates the degree of myocardial injury in patients with acute ST-elevation myocardial infarction. Chin Med J (Engl). 2013 Oct;126(20):3926-9.
Zhang B, Peng W, Wang C, Li W, Xu Y. A low fT3 level as a prognostic marker in patients with acute myocardial infarctions. Intern Med. 2012;51(21):3009-15. doi: 10.2169/internalmedicine.51.7902. Epub 2012 Nov 1.
Mourouzis I, Giagourta I, Galanopoulos G, Mantzouratou P, Kostakou E, Kokkinos AD, Tentolouris N, Pantos C. Thyroid hormone improves the mechanical performance of the post-infarcted diabetic myocardium: a response associated with up-regulation of Akt/mTOR and AMPK activation. Metabolism. 2013 Oct;62(10):1387-93. doi: 10.1016/j.metabol.2013.05.008. Epub 2013 Jun 15.
Mourouzis I, Mantzouratou P, Galanopoulos G, Kostakou E, Roukounakis N, Kokkinos AD, Cokkinos DV, Pantos C. Dose-dependent effects of thyroid hormone on post-ischemic cardiac performance: potential involvement of Akt and ERK signalings. Mol Cell Biochem. 2012 Apr;363(1-2):235-43. doi: 10.1007/s11010-011-1175-9. Epub 2011 Dec 2.
Tang YD, Kuzman JA, Said S, Anderson BE, Wang X, Gerdes AM. Low thyroid function leads to cardiac atrophy with chamber dilatation, impaired myocardial blood flow, loss of arterioles, and severe systolic dysfunction. Circulation. 2005 Nov 15;112(20):3122-30. doi: 10.1161/CIRCULATIONAHA.105.572883. Epub 2005 Nov 7.
Related Links
Access external resources that provide additional context or updates about the study.
heart attack
hypothyroidism
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Z15110700400000
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.