Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02512978|
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Hypothyroidism||Drug: Levothyroxine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Levothyroxine group
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
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.
- The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging [ Time Frame: within 6 months of patient enrolled ]
- 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
- The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE) [ Time Frame: 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.
- Death by any cause [ Time Frame: Within 12 months of patient enrolled ]
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
|Contact: Wen-Yao Wang, MD,PhD Candidate||8618810488381 ext firstname.lastname@example.org|
|Contact: Jing Chen, MD||8618618285284 ext email@example.com|
|Fuwai Cardiovascular Hospital||Recruiting|
|Beijing, China, 100037|
|Contact: Kuo Zhang, MD,PhD Candidant +86 18813019602 firstname.lastname@example.org|
|Principal Investigator:||Yi-Da Tang, MD,PhD||Chinese Academy of Medical Sciences, Fuwai Hospital|