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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03933358

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 3, 2019

Study Description

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:Thyroid
    Cardiac Remodeling, Ventricular
    STEMI
  • Intervention/Treatment: Other: Thyroid hormone levels
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Groups and Cohorts
Groups/Cohorts 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
  • 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
  • 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
Contacts

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

Locations

China
Beijing Friendship Hospital, Capital Medical University
Beijing

Sponsors and Collaborators

Beijing Friendship Hospital

More Information
  • Responsible Party: Beijing Friendship Hospital
  • ClinicalTrials.gov Identifier: NCT03933358 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Thyroid Diseases
    Ventricular Remodeling
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction