Back to results

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

Primary Purpose

Myocardial Infarction, Hypothyroidism

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Levothyroxine

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, hypothyroidism, levothyroxine, cardiac magnetic resonance imaging, myocardial perfusion/metabolism radionuclide imaging, myocardial fibrosis, myocardial perfusion/metabolism, cardiac function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Fuwai Cardiovascular HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Levothyroxine group

Standard therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Major adverse cardiac and cerebrovascular events

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

Death by any cause

Full Information

NCT ID

NCT02512978

First Posted

July 27, 2015

Last Updated

July 13, 2018

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Beijing Municipal Science & Technology Commission, Peking Union Medical College Hospital, Peking University Third Hospital, Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, The Luhe Teaching Hospital of the Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02512978

Brief Title

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

Official Title

Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Hypothyroidism

Keywords

myocardial infarction, hypothyroidism, levothyroxine, cardiac magnetic resonance imaging, myocardial perfusion/metabolism radionuclide imaging, myocardial fibrosis, myocardial perfusion/metabolism, cardiac function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levothyroxine group

Arm Type

Experimental

Arm Description

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

Arm Title

Standard therapy group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Levothyroxine

Other Intervention Name(s)

Euthyrox

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

within 6 months of patient enrolled

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Within 6 months of patient enrolled

Title

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

Time Frame

Within 6 months of patient enrolled

Title

Major adverse cardiac and cerebrovascular events

Description

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

Time Frame

within 12 months of patient enrolled

Title

Death by any cause

Time Frame

Within 12 months of patient enrolled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen-Yao Wang, MD,PhD Candidate

Phone

8618810488381

Ext

861088396171

wwypumc@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jing Chen, MD

Phone

8618618285284

Ext

861088396171

tyler_1985@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi-Da Tang, MD,PhD

Organizational Affiliation

Chinese Academy of Medical Sciences, Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Cardiovascular Hospital

City

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kuo Zhang, MD,PhD Candidant

Phone

+86 18813019602

zk1989y@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

24969506

Citation

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.

Results Reference

result

PubMed Identifier

21568669

Citation

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.

Results Reference

result

PubMed Identifier

21765997

Citation

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.

Results Reference

result

PubMed Identifier

23448784

Citation

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.

Results Reference

result

PubMed Identifier

15247962

Citation

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.

Results Reference

result

PubMed Identifier

17964598

Citation

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.

Results Reference

result

PubMed Identifier

24951271

Citation

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.

Results Reference

result

PubMed Identifier

24157158

Citation

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.

Results Reference

result

PubMed Identifier

23124142

Citation

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.

Results Reference

result

PubMed Identifier

23773982

Citation

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.

Results Reference

result

PubMed Identifier

22134702

Citation

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.

Results Reference

result

PubMed Identifier

16275864

Citation

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.

Results Reference

result

Links:

URL

http://www.nlm.nih.gov/medlineplus/heartattack.html

Description

heart attack

URL

http://www.nlm.nih.gov/medlineplus/hypothyroidism.html

Description

hypothyroidism

URL

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682461.html

Description

levothyroxine

Learn more about this trial

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

We'll reach out to this number within 24 hrs