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Myocardial InfarctionPhase 4NCT02512978

Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

A Phase 4 study testing Levothyroxine in people with Myocardial Infarction and Hypothyroidism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction, Hypothyroidism
What is being tested?
Levothyroxine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
Aug 2015to Jun 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 75, male or non-pregnant female;
  • Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
  • With presence of hypothyroid status (i.e., TSH >7.0 mIU/L and (or) fT3 <1.79 pg/mL);
  • Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Who cannot join

  • Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
  • Symptoms of severe heart failure (Killip Class III and above);
  • Severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
  • Impaired liver function before surgery: Serum GPT > 120U/L;
  • Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
  • Those taking medicine which can affect the test of thyroid function;
Show all 9Show fewer
  • Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
  • Those having prior myocardial infarction;
  • Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Trial locations and contacts

1 site in 1 country.

Wen-Yao Wang, MD,PhD Candidate contact

8618810488381 ext. 861088396171

wwypumc@126.com

Jing Chen, MD contact

8618618285284 ext. 861088396171

tyler_1985@163.com

China1 site, 1 recruiting

  • Fuwai Cardiovascular Hospital

    Beijing, 100037

    Kuo Zhang, MD,PhD Candidant, +86 18813019602, zk1989y@163.com

    Recruiting

Other trials in China

About this study

Official title: Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction

Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

Read the detailed description

The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Being tested
Levothyroxine
Keywords
myocardial infarction, hypothyroidism, levothyroxine, cardiac magnetic resonance imaging, myocardial perfusion/metabolism radionuclide imaging, myocardial fibrosis, myocardial perfusion/metabolism, cardiac function
Medical subject headings
Myocardial Infarction, Hypothyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevothyroxineDrug

    Also called Euthyrox

    Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.

Study groups in NCT02512978
Study groupRoleWhat they receive
Levothyroxine groupExperimentalThe patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Receives: Drug: Levothyroxine
Standard therapy groupNo interventionThe patients in this group receive standard therapy in consistent with the local clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging

    Measured: within 6 months of patient enrolled

Secondary outcomes (4)

  1. Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging

    Patterns of myocardial perfusion/metabolism were classified as normal, mismatch, mild-moderate match and severe match

    Measured: Within 6 months of patient enrolled

  2. The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)

    Measured: Within 6 months of patient enrolled

  3. Major adverse cardiac and cerebrovascular events

    The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident.

    Measured: within 12 months of patient enrolled

  4. Death by any cause

    Measured: Within 12 months of patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02512978
Sponsor's protocol ID
Z15110700400000
Status last verified
Jul 2018
First submitted
27 Jul 2015
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24969506

  • 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.

    PubMed 21568669

  • 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.

    PubMed 21765997

  • 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.

    PubMed 23448784

  • 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.

    PubMed 15247962

  • 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.

    PubMed 17964598

  • 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.

    PubMed 24951271

  • 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.

    PubMed 24157158

  • 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.

    PubMed 23124142

  • 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.

    PubMed 23773982

  • 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.

    PubMed 22134702

  • 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.

    PubMed 16275864

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levothyroxine in people with Myocardial Infarction and Hypothyroidism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wen-Yao Wang, MD,PhD Candidate (8618810488381 ext. 861088396171, wwypumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging (time frame: within 6 months of patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02512978, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.

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