- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933358
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients (ThyREST)
May 1, 2019 updated by: Hongwei Li, MD, Beijing Friendship Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Recruiting
- Beijing Friendship Hospital, Capital Medical University
-
Contact:
- Wen Su
- Email: 15901120705@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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Description
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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Euthyroid
|
This is an observational study.
Exposure: Different thyroid hormone levels.
|
Low T3
low triiodothyronine syndrome
|
This is an observational study.
Exposure: Different thyroid hormone levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE (major adverse cardiovascular events)
Time Frame: 12 months
|
cardiovascular death, re-infarction, revascularization, and stroke
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
all-cause death
Time Frame: 12 months
|
death caused by all reason
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
May 1, 2019
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
April 29, 2019
First Posted (Actual)
May 1, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2019
Last Update Submitted That Met QC Criteria
May 1, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Endocrine System Diseases
- Pathological Conditions, Anatomical
- Myocardial Infarction
- Infarction
- ST Elevation Myocardial Infarction
- Thyroid Diseases
- Ventricular Remodeling
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- BFH-Thyroid and STEMI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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