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

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ClinicalTrials.gov Identifier: NCT02512978
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : July 16, 2018
Sponsor:
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
Information provided by (Responsible Party):
Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Hypothyroidism Drug: Levothyroxine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Levothyroxine group
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Drug: Levothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Other Name: Euthyrox

No Intervention: Standard therapy group
The patients in this group receive standard therapy in consistent with the local clinical practice.



Primary Outcome Measures :
  1. The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging [ Time Frame: within 6 months of patient enrolled ]

Secondary Outcome Measures :
  1. Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging [ Time Frame: Within 6 months of patient enrolled ]
    Patterns of myocardial perfusion/metabolism were classified as normal, mismatch, mild-moderate match and severe match

  2. The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE) [ Time Frame: Within 6 months of patient enrolled ]
  3. Major adverse cardiac and cerebrovascular events [ Time Frame: within 12 months of patient enrolled ]
    The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident.

  4. Death by any cause [ Time Frame: Within 12 months of patient enrolled ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 75, male or non-pregnant female;
  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:

  1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512978


Contacts
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Contact: Wen-Yao Wang, MD,PhD Candidate 8618810488381 ext 861088396171 wwypumc@126.com
Contact: Jing Chen, MD 8618618285284 ext 861088396171 tyler_1985@163.com

Locations
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China
Fuwai Cardiovascular Hospital Recruiting
Beijing, China, 100037
Contact: Kuo Zhang, MD,PhD Candidant    +86 18813019602    zk1989y@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
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
Investigators
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Principal Investigator: Yi-Da Tang, MD,PhD Chinese Academy of Medical Sciences, Fuwai Hospital

Additional Information:
Publications of Results:

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Responsible Party: Yi-Da Tang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT02512978     History of Changes
Other Study ID Numbers: Z15110700400000
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Keywords provided by Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital:
myocardial infarction
hypothyroidism
levothyroxine
cardiac magnetic resonance imaging
myocardial perfusion/metabolism radionuclide imaging
myocardial fibrosis
myocardial perfusion/metabolism
cardiac function
Additional relevant MeSH terms:
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Myocardial Infarction
Hypothyroidism
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs