NCT03933358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

April 29, 2019

Last Update Submit

May 1, 2019

Conditions

ThyroidCardiac Remodeling, VentricularSTEMI

Outcome Measures

Primary Outcomes (1)

  • MACE (major adverse cardiovascular events)

    cardiovascular death, re-infarction, revascularization, and stroke

    12 months

Secondary Outcomes (2)

  • adverse cardiac remodeling

    6 months

  • all-cause death

    12 months

Study Arms (2)

Euthyroid

Other: Thyroid hormone levels

Low T3

low triiodothyronine syndrome

Other: Thyroid hormone levels

Interventions

Thyroid hormone levelsOTHER

This is an observational study. Exposure: Different thyroid hormone levels.

EuthyroidLow T3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Beijing Friendship Hospital with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Thyroid DiseasesVentricular RemodelingST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Endocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Central Study Contacts

Hongwei Li

CONTACT

0086 10 63139780lhw19656@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 1, 2019

Study Start

May 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

CN(1)