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

July 13, 2018 updated by: Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen-Yao Wang, MD,PhD Candidate
  • Phone Number: 861088396171 8618810488381
  • Email: wwypumc@126.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Cardiovascular Hospital
        • Contact:
          • Kuo Zhang, MD,PhD Candidant
          • Phone Number: +86 18813019602
          • Email: zk1989y@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Euthyrox
NO_INTERVENTION: Standard therapy group
The patients in this group receive standard therapy in consistent with the local clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging
Time Frame: within 6 months of patient enrolled
within 6 months of patient enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 6 months of patient enrolled
The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)
Time Frame: Within 6 months of patient enrolled
Within 6 months of patient enrolled
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.
within 12 months of patient enrolled
Death by any cause
Time Frame: Within 12 months of patient enrolled
Within 12 months of patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

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

Investigators

  • Principal Investigator: Yi-Da Tang, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (ESTIMATE)

July 31, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z15110700400000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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