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

Phase 4

• Conditions: Myocardial Infarction; Hypothyroidism
• Interventions: Drug: Levothyroxine

• Registration Number: NCT02512978
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-31
• Study Start: 2015-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-16
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levothyroxine group	Levothyroxine	The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.

Primary Outcome Measures

Name	Time	Method
The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging	within 6 months of patient enrolled

Secondary Outcome Measures

Name	Time	Method
Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging	Within 6 months of patient enrolled	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)	Within 6 months of patient enrolled
Major adverse cardiac and cerebrovascular events	within 12 months of patient enrolled	The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident.
Death by any cause	Within 12 months of patient enrolled

Trial Locations

Locations (1)

Fuwai Cardiovascular Hospital; 🇨🇳 Beijing, China