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Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients (ThyREST)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933358
Recruitment Status : Unknown
Verified May 2019 by Hongwei Li, MD, Beijing Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : May 1, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hongwei Li, MD, Beijing Friendship Hospital

Study Description
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Brief Summary:
This study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with STEMI receiving primary percutaneous coronary intervention.

Condition or disease Intervention/treatment
Thyroid Cardiac Remodeling, Ventricular STEMI Other: Thyroid hormone levels

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort Intervention/treatment
Euthyroid Other: Thyroid hormone levels
This is an observational study. Exposure: Different thyroid hormone levels.
Low T3
low triiodothyronine syndrome
 Other: Thyroid hormone levels
This is an observational study. Exposure: Different thyroid hormone levels.


Outcome Measures
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Primary Outcome Measures :
  1. MACE (major adverse cardiovascular events) [ Time Frame: 12 months ]
    cardiovascular death, re-infarction, revascularization, and stroke


Secondary Outcome Measures :
  1. adverse cardiac remodeling [ Time Frame: 6 months ]
    a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans

  2. all-cause death [ Time Frame: 12 months ]
    death caused by all reason


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Criteria

Inclusion Criteria:

  • with a confirmed STEMI diagnosis
  • undergoing primary percutaneous coronary intervention (presenting <12h after symptom onset)
  • patients agreed and provided informed consent

Exclusion Criteria:

  • past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft
  • past history of heart failure (LVEF<40%) or myocardiopathy or atrial fibrillation
  • past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission
  • contraindicating to cardiac magnetic resonance imaging
Contacts and Locations
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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): NCT03933358


Contacts
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Contact: Hongwei Li 0086 10 63139780 lhw19656@sina.com

Locations
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China
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Wen Su       15901120705@163.com   
Sponsors and Collaborators
Beijing Friendship Hospital
More Information
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Responsible Party: Hongwei Li, MD, Prof., Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03933358    
Other Study ID Numbers: BFH-Thyroid and STEMI
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Thyroid Diseases
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs