ThyroidThyRESTNCT03933358
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients
An observational study of Thyroid and Cardiac Remodeling, Ventricular, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid, Cardiac Remodeling, Ventricular, STEMI
- What is being tested?
- Thyroid hormone levels
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Who may be able to join
- with a confirmed STEMI diagnosis
- undergoing primary percutaneous coronary intervention (presenting <12h after symptom onset)
- patients agreed and provided informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Wen Su, 15901120705@163.com
About this study
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.
- Conditions
- Thyroid, Cardiac Remodeling, Ventricular, STEMI
- Being tested
- Thyroid hormone levels
- Medical subject headings
- Thyroid Diseases, Ventricular Remodeling, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid hormone levelsOther
This is an observational study. Exposure: Different thyroid hormone levels.
| Study group | Role | What they receive |
|---|---|---|
| Euthyroid | Not described Receives: Other: Thyroid hormone levels | |
| Low T3 | low triiodothyronine syndrome Receives: Other: Thyroid hormone levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (major adverse cardiovascular events)
cardiovascular death, re-infarction, revascularization, and stroke
Measured: 12 months
Secondary outcomes (2)
adverse cardiac remodeling
a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans
Measured: 6 months
all-cause death
death caused by all reason
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933358
- Sponsor's protocol ID
- BFH-Thyroid and STEMI
- Acronym
- ThyREST
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients
- ClinicalTrials.gov ID
- NCT03933358
- Acronym / sponsor ID
- ThyREST / BFH-Thyroid and STEMI
- Conditions
- Thyroid, Cardiac Remodeling, Ventricular, STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euthyroid | – | Other: Thyroid hormone levels |
| Low T3 | – | Other: Thyroid hormone levelslow triiodothyronine syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Key inclusion criteria (3 listed)
- with a confirmed STEMI diagnosis
- undergoing primary percutaneous coronary intervention (presenting <12h after symptom onset)
- patients agreed and provided informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid hormone levelsThis is an observational study. Exposure: Different thyroid hormone levels. | Other | Euthyroid, Low T3 |
Primary outcome
MACE (major adverse cardiovascular events)
Time frame: 12 months
cardiovascular death, re-infarction, revascularization, and stroke
2 secondary outcomes
adverse cardiac remodeling
Time frame: 6 months
all-cause death
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Cardiac Remodeling, Ventricular, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Li (0086 10 63139780, lhw19656@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (major adverse cardiovascular events) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.