NCT02512978

Brief 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. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

July 27, 2015

Last Update Submit

July 13, 2018

Conditions

Myocardial InfarctionHypothyroidism

Keywords

myocardial infarctionhypothyroidismlevothyroxinecardiac magnetic resonance imagingmyocardial perfusion/metabolism radionuclide imagingmyocardial fibrosismyocardial perfusion/metabolismcardiac function

Outcome Measures

Primary Outcomes (1)

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

    within 6 months of patient enrolled

Secondary Outcomes (4)

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

    Within 6 months of patient enrolled

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

    Within 6 months of patient enrolled

  • Major adverse cardiac and cerebrovascular events

    within 12 months of patient enrolled

  • Death by any cause

    Within 12 months of patient enrolled

Study Arms (2)

Levothyroxine group

EXPERIMENTAL

The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.

Drug: Levothyroxine

Standard therapy group

NO INTERVENTION

The patients in this group receive standard therapy in consistent with the local clinical practice.

Interventions

LevothyroxineDRUG

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

Also known as: Euthyrox
Levothyroxine group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Cardiovascular Hospital

Beijing, 100037, China

RECRUITING

Related Publications (12)

  • 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.

    PMID: 24969506RESULT

  • 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.

    PMID: 21568669RESULT

  • 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.

    PMID: 21765997RESULT

  • 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.

    PMID: 23448784RESULT

  • 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.

    PMID: 15247962RESULT

  • 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.

    PMID: 17964598RESULT

  • 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.

    PMID: 24951271RESULT

  • 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.

    PMID: 24157158RESULT

  • 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.

    PMID: 23124142RESULT

  • 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.

    PMID: 23773982RESULT

  • 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.

    PMID: 22134702RESULT

  • 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.

    PMID: 16275864RESULT

Related Links

MeSH Terms

Conditions

Myocardial InfarctionHypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisThyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Yi-Da Tang, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Yao Wang, MD,PhD Candidate

CONTACT

8618810488381wwypumc@126.com

Jing Chen, MD

CONTACT

8618618285284tyler_1985@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 31, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

CN(1)